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Mechanical Engineer jobs at Genentech

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  • Principal Mechanical Engineer Project Manager

    Genentech 4.5company rating

    Mechanical engineer job at Genentech

    Genentech is establishing a new Campus Development Team (CDT) to oversee the implementation of the Campus Vision Plan (CVP) for the South San Francisco campus. This Senior Principal Mechanical Engineer position provides single-point accountability for the successful end-to-end delivery of all Mechanical systems, with a primary focus on the complex laboratory and research environments within the gRED development. This role will also provide expertise for the supporting Vivarium, Utility Plant, and Electrical Distribution Hub as part of the CVP. The Principal Mechanical Engineer works within a large, cross-functional project organization and serves as the primary technical liaison, coordinating the specific mechanical systems (HVAC, plumbing, fire protection, building controls, automation and energy management) and reliability needs of scientific and vivarium user groups into actionable engineering designs. This position is responsible for ensuring all mechanical systems are delivered safely, on schedule, within budget, and to the highest standards of quality, meeting the critical demands of a world-class R&D and animal care facility. The OpportunityResponsibilities: The responsibilities for this position may include, but are not limited to: ● Provides technical leadership and deep subject matter expertise for the mechanical engineering designs supporting gRED research laboratories, specialized vivarium spaces, and associated supporting projects. ● Actively leads the design and planning of HVAC, plumbing, fire protection, building controls, automation and energy management critical to laboratory operations and specialized vivarium environments. ● Coordinates with the Utility Master Plans to ensure that upgrades to critical mechanical infrastructure (including the Regional Utility Plant and Electrical Distribution Hub) directly support the reliability, redundancy and scalability required by the new lab facilities. ● Serves as a respected industry expert on laboratory mechanical design, engaging with the Roche/Genentech internal and industry external network to learn, influence, and collaborate on new technologies and best practices for gRED. ● Primary focus will be ensuring scientific user requirements are incorporated into robust technical solutions for the gRED project. ● Provide expert design guidance on HVAC, plumbing, fire protection, building controls, automation and energy management to labs and strategies for flexible 'plug-and-play' capabilities, and robust back-up systems to protect critical experiments, data, and animal life-support systems. ● Work closely with other technical leads to ensure seamless integration of HVAC, plumbing, fire protection, building controls, automation and energy management systems with lab-specific platforms like Building Automation Systems (BAS) and environmental monitoring systems. ● Serve as the mechanical SME in all design and user-group meetings, providing clear technical options analysis and advocating for designs that prioritize scientific workflow, flexibility, and safety. ● A key function of this role will also be to ensure all mechanical designs align with Roche/Genentech and site-specific standards, with a particular focus on standards governing laboratory design and vivarium operations. ● Coordinates the mechanical scope into a comprehensive strategy to address the technical needs across all aspects of the gRED project, from main infrastructure to the point-of-use in the lab. ● A portion of the Principal Mechanical Engineer's time will be spent supporting broad Design Engineering & Construction Services process improvement projects and LEAN initiatives, applying these principles to improve the lab design and delivery process. ● The Senior Principal Mechanical Engineer will be responsible for driving innovation in mechanical systems specifically for R&D environments, adopting technologies that improve lab flexibility, energy efficiency, and operational reliability. ● This role will participate in the development of a project-wide mechanical infrastructure strategy, in partnership with the Design team, to ensure the new gRED labs are adaptable for future scientific platforms and technologies, reducing total cost of ownership while maximizing uptime and research continuity. ● A key portion of the role is continuous learning, engagement with the Roche engineering network (technical experts within the Roche Global organization and other Roche sites) as well as outside industry organizations, including ASHRAE, ISPE and others. Key Tasks: ● Project Planning and Coordination: Develop and maintain a comprehensive project plan, coordinating with architects, engineers, and contractors. Apply innovative thinking to proactively identify and mitigate risks, while monitoring progress via KPIs and reporting status to senior management. ● Budgeting and Resource Management: Support the development and management of the project budget, ensuring cost control and effective resource allocation. This role also supports all procurement activities, including vendor selection, contract negotiation, and material acquisitions. ● Stakeholder Management: Build and maintain strong relationships with internal and external stakeholders, fostering collaboration, transparency, and alignment. Serve as a trusted liaison, keeping all parties informed and engaged through regular meetings and progress reports. ● Team Leadership: Provide effective leadership by clarifying roles and fostering a collaborative, motivated work environment. Mentor and guide team members while also contributing strategic design and technical expertise to the facility's construction. ● Quality Control: Implement and enforce strict quality control measures to ensure compliance with industry standards and specifications.. Who You Are Requirements: ● Bachelor's degree in Mechanical Engineering or equivalent. ● 15 years or more pharmaceutical technology experience in industry or academia after receiving their Bachelor's Degree, at least 8 of which involved mechanical system design, construction and\or commissioning and qualification activities. ● Working knowledge of ANSI / ASHRAE, NEMA, NFPA, EPA, and OSHA standards as well as relevant chemical industry specific standards and documentation (piping and instrumentation diagrams, process flow diagrams). ● Pharmaceutical GMP project mechanical design experience, LEED certification, experience in project management, LEAN / Six Sigma certification, and/or experience working in a campus environment highly desired, but not required. ● Must have excellent communication (written/verbal), presentation, leadership, interpersonal, collaborative, conflict resolution, and negotiating skills ● Excellent organization and planning skills. ● Advanced Microsoft Office and Google Suite skills. ● Exceptional teamwork and collaboration skills are essential to facilitate the work of cross-functional and interdepartmental teams. ● Must be dependable, provide attention to details, and execute proficiently in coordination tasks. ● Self-starter and ability to work with minimum or no supervision. Relocation benefits are not available for this posting. The expected salary range for this position based on the primary location of California is $168,10000 - $312,300 USD Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $168.1k-312.3k yearly Auto-Apply 14d ago
  • Principal Mechanical Engineer Project Manager

    Genentech 4.5company rating

    Mechanical engineer job at Genentech

    ** Genentech is establishing a new Campus Development Team (CDT) to oversee the implementation of the Campus Vision Plan (CVP) for the South San Francisco campus. This Senior Principal Mechanical Engineer position provides single-point accountability for the successful end-to-end delivery of all Mechanical systems, with a primary focus on the complex laboratory and research environments within the gRED development. This role will also provide expertise for the supporting Vivarium, Utility Plant, and Electrical Distribution Hub as part of the CVP. The Principal Mechanical Engineer works within a large, cross-functional project organization and serves as the primary technical liaison, coordinating the specific mechanical systems (HVAC, plumbing, fire protection, building controls, automation and energy management) and reliability needs of scientific and vivarium user groups into actionable engineering designs. This position is responsible for ensuring all mechanical systems are delivered safely, on schedule, within budget, and to the highest standards of quality, meeting the critical demands of a world-class R&D and animal care facility. **The Opportunity** **Responsibilities:** The responsibilities for this position may include, but are not limited to: ● Provides technical leadership and deep subject matter expertise for the mechanical engineering designs supporting gRED research laboratories, specialized vivarium spaces, and associated supporting projects. ● Actively leads the design and planning of HVAC, plumbing, fire protection, building controls, automation and energy management critical to laboratory operations and specialized vivarium environments. ● Coordinates with the Utility Master Plans to ensure that upgrades to critical mechanical infrastructure (including the Regional Utility Plant and Electrical Distribution Hub) directly support the reliability, redundancy and scalability required by the new lab facilities. ● Serves as a respected industry expert on laboratory mechanical design, engaging with the Roche/Genentech internal and industry external network to learn, influence, and collaborate on new technologies and best practices for gRED. ● Primary focus will be ensuring scientific user requirements are incorporated into robust technical solutions for the gRED project. ● Provide expert design guidance on HVAC, plumbing, fire protection, building controls, automation and energy management to labs and strategies for flexible 'plug-and-play' capabilities, and robust back-up systems to protect critical experiments, data, and animal life-support systems. ● Work closely with other technical leads to ensure seamless integration of HVAC, plumbing, fire protection, building controls, automation and energy management systems with lab-specific platforms like Building Automation Systems (BAS) and environmental monitoring systems. ● Serve as the mechanical SME in all design and user-group meetings, providing clear technical options analysis and advocating for designs that prioritize scientific workflow, flexibility, and safety. ● A key function of this role will also be to ensure all mechanical designs align with Roche/Genentech and site-specific standards, with a particular focus on standards governing laboratory design and vivarium operations. ● Coordinates the mechanical scope into a comprehensive strategy to address the technical needs across all aspects of the gRED project, from main infrastructure to the point-of-use in the lab. ● A portion of the Principal Mechanical Engineer's time will be spent supporting broad Design Engineering & Construction Services process improvement projects and LEAN initiatives, applying these principles to improve the lab design and delivery process. ● The Senior Principal Mechanical Engineer will be responsible for driving innovation in mechanical systems specifically for R&D environments, adopting technologies that improve lab flexibility, energy efficiency, and operational reliability. ● This role will participate in the development of a project-wide mechanical infrastructure strategy, in partnership with the Design team, to ensure the new gRED labs are adaptable for future scientific platforms and technologies, reducing total cost of ownership while maximizing uptime and research continuity. ● A key portion of the role is continuous learning, engagement with the Roche engineering network (technical experts within the Roche Global organization and other Roche sites) as well as outside industry organizations, including ASHRAE, ISPE and others. **Key Tasks** : ● Project Planning and Coordination: Develop and maintain a comprehensive project plan, coordinating with architects, engineers, and contractors. Apply innovative thinking to proactively identify and mitigate risks, while monitoring progress via KPIs and reporting status to senior management. ● Budgeting and Resource Management: Support the development and management of the project budget, ensuring cost control and effective resource allocation. This role also supports all procurement activities, including vendor selection, contract negotiation, and material acquisitions. ● Stakeholder Management: Build and maintain strong relationships with internal and external stakeholders, fostering collaboration, transparency, and alignment. Serve as a trusted liaison, keeping all parties informed and engaged through regular meetings and progress reports. ● Team Leadership: Provide effective leadership by clarifying roles and fostering a collaborative, motivated work environment. Mentor and guide team members while also contributing strategic design and technical expertise to the facility's construction. ● Quality Control: Implement and enforce strict quality control measures to ensure compliance with industry standards and specifications.. **Who You Are** **Requirements:** ● Bachelor's degree in Mechanical Engineering or equivalent. ● 15 years or more pharmaceutical technology experience in industry or academia after receiving their Bachelor's Degree, at least 8 of which involved mechanical system design, construction and\or commissioning and qualification activities. ● Working knowledge of ANSI / ASHRAE, NEMA, NFPA, EPA, and OSHA standards as well as relevant chemical industry specific standards and documentation (piping and instrumentation diagrams, process flow diagrams). ● Pharmaceutical GMP project mechanical design experience, LEED certification, experience in project management, LEAN / Six Sigma certification, and/or experience working in a campus environment highly desired, but not required. ● Must have excellent communication (written/verbal), presentation, leadership, interpersonal, collaborative, conflict resolution, and negotiating skills ● Excellent organization and planning skills. ● Advanced Microsoft Office and Google Suite skills. ● Exceptional teamwork and collaboration skills are essential to facilitate the work of cross-functional and interdepartmental teams. ● Must be dependable, provide attention to details, and execute proficiently in coordination tasks. ● Self-starter and ability to work with minimum or no supervision. Relocation benefits are not available for this posting. The expected salary range for this position based on the primary location of California is $168,10000 - $312,300 USD Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits (******************************** Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (***************************************************************************************************** .
    $168.1k-312.3k yearly 13d ago
  • Staff Mechanical Engineer

    Philips Healthcare 4.7company rating

    San Diego, CA jobs

    Job TitleStaff Mechanical EngineerJob Description We are looking for a Staff Mechanical Development Engineer who will be responsible for the mechanical design and development of wearable medical monitoring devices, accessories, and associated equipment. Your role: Create 3D CAD models and detailed 2D drawings of parts and assemblies of wearable electronic medical devices. Design for functionality, reliability, usability, manufacturability, and aesthetics to ensure product excellence. Develop parts and assemblies for high volume processes such as plastic injection molding and die cutting while maintaining high quality and consistency standards. Drive the mechanical engineering development activities across Innovation, NPI and Sustaining projects for a wearable medical device Design high-volume die cut and converted parts and assemblies suitable for manufacturing and production environments. Conduct root cause analysis of issues to improve designs and successfully take products from concept to production ensuring regulatory compliance. You're the Right Fit If: You hold a bachelor's degree in mechanical engineering (advanced degree preferred) with a minimum of 10 years of experience in an FDA-regulated environment, demonstrating a strong track record of success in delivering compliant products. You are proficient with 3D CAD modeling systems and workflow, especially SolidWorks or Onshape, and have a solid foundation in mathematics and physical modeling, enabling precise and efficient design processes. You possess deep knowledge of the material properties of metals, plastic resins, and adhesives, and understand their compatibility with chemicals used for reprocessing, ensuring durability and performance in medical contexts. You are experienced in applying medical device safety standards and using FEA and other analysis tools to make informed design decisions that enhance product reliability, safety, and efficacy. You excel in collaborating with other engineering disciplines and industrial designers, backed by excellent communication and interpersonal skills, as well as robust project management expertise to lead projects effectively. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is an office role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. Learn more about our culture. Philips Transparency Details The pay range for this position in (San Diego, Ca) is $139,400 to $223,000.00 The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. Additional Information US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to San Diego, Ca. #LI-PH1 #Connected Care This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.
    $139.4k-223k yearly Auto-Apply 9d ago
  • Senior Mechanical Engineer

    Bio-Rad Laboratories 4.7company rating

    Hercules, CA jobs

    Working within Bio-Rad's Clinical Diagnostics Group R&D organization as an Instrument Engineer with Mechanical Engineering background, you'll take engineering concepts and requirements and transform them into functional prototypes and finished products that improve healthcare outcomes for people around the world. Leveraging your knowledge of engineering principles and best practices, you'll have an active role in the development and testing of new products. You'll also collaborate with a multi-disciplinary team of engineers and scientists, providing your technical knowledge and insights to ensure our products deliver the highest levels of quality and functionality. As a Senior Mechanical Engineer, you will participate and provide leadership in the mechanical design of new electromechanical IVD instrumentation and consumables. This includes providing specifications creation, performing engineering modeling and analyses, developing test methods and fixtures, documenting, and communicating the design to internal stakeholders and external suppliers. This role demands significant creativity and will require experience using best engineering practices in the design, analysis and verification of components, assemblies, mechanisms, and systems. How You'll Make An Impact: Technical Development and Analysis * Design, develop, prototype, measure, modify, and test mechanical systems as part of electromechanical equipment development. Specification and qualification of new mechanical designs. * Design with knowledge of materials and manufacturing processes and understand the interdependencies/design constraints with other project team members. * Exhibit cooperation and sound judgment in design tradeoffs resulting in reliable designs. * Design for: Quality, Reliability, Serviceability, Manufacturability, Test and Product Cost while meeting the needs of the customer. Complete new equipment/component installations, preventative maintenance activities, and emergency repairs with proper supporting documentation in compliance with Quality Assurance. * Conduct simulation of systems as appropriate to assure product performance. * Diagnose the causes of system failures and specify solutions. * Support production of final product by troubleshooting process and component problems * Provide engineering support to Manufacturing, Materials, Test Engineering, and Service to facilitate transfer of designs * Assess field reliability data and improve existing product designs as necessary * Shepherd projects through the design control process (design specification, design review, risk analysis, etc.), and support New Product Introduction personnel in initial builds (procurement, assembly, troubleshooting) * Assist in supporting instrument fleet repairs for legacy and NPD instruments, identify design improvements for future development/ sustaining engineering activtiies, and coordinate with scientists, SW/HW engineers in finding resolutions for issues identified. Project Management and Documentation * Maintain rigorous documentation for all phases of product development, including design specifications, test plans, CAD models, drawings, and change orders associated with IVD instruments and accessories. * Participate in developing & executing project plans, adhere to milestones, and manage concurrent projects. * Routine communication with peers and supervisors including documentation of work, meetings, and decisions. Ensure that meetings, project reviews and action lists are kept current and communicated to all stakeholders in a timely fashion. * Interface with manufacturing and supply chain teams to ensure smooth transfer of products into production. * Direct outside contract personnel as needed for completion of specific tasks. Quality, Compliance, and Regulated Practices * Support compliance to regulatory requirements including electromagnetic interference/electromagnetic compatibility (EMI/EMC), Underwriters Laboratories (UL), REACH/RoHS and other environmental standards. * Perform work in adherence to the Quality Management System (QMS), including development and maintenance of documentation. * Ensure designs meet requirements regulated by FDA, UL, IEC, CE, and other governing bodies. * Participate in selection of vendors and fabrication sources to assure quality and compliance to released specifications. What You Bring: * Education: B.S. in Mechanical Engineering is a must * Work Experience: 5+ years industry related experience. * Strong troubleshooting skills and communication skills a must * Ability to lift, carry, push, pull or otherwise move approximately 80-100 lbs * Experience supporting laboratory equipment is desired. * Understanding of automation design. * High Proficiency using software like 3D CAD to design mechanisms; SolidWorks preferred (3D design & surfacing), Matlab, Finite Element Analysis (such as Ansys/ Pro Mechanica). * Programming in Matlab to interface with electro-mechanical assemblies and perform data analysis. * Machining & high volume injection molding experience is a plus. Total Rewards Package: At Bio-Rad, we're empowered by our purpose and recognize that our employees are as well. That's why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee's work and life cycle. Benefits: We're proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability, paid parental leave, 401k plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges and support, paid time off, Employee Resource Groups (ERG's), and more! Compensation: The estimated base salary range for this position is $117,900 to $162,200 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. This position is eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance. Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see. EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply. Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes. Fraud Alert: Bio-Rad has received reports of individuals posing as Bio-Rad recruiters to obtain information, including personal and financial, from applicants. Beware of these fake "recruiters" and job scams. Click here for more information on this scam and how to avoid it. #LI-AK1 Legal Entity: (USA_1000) Bio-Rad Laboratories, Inc.
    $117.9k-162.2k yearly Auto-Apply 14d ago
  • Principal R&D Design Engineer

    Edwards Lifesciences Corp 4.6company rating

    Irvine, CA jobs

    Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease. As part of our R&D Engineering team, you will work closely with our Quality and Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients' lives around the world. Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients' quality of life and expand their potential treatment opportunities. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you will make an impact: With a strong emphasis on innovation, our Surgical Structural Heart (SSH) business unit is dedicated to addressing significant unmet needs within the field of cardiac surgery. This position with the Design and Simulation Team offers an opportunity to advance design capabilities within the SSH R&D group, contributing to the improvement of current and emerging technologies and therapies. Primary roles and responsibilities include: * Lead in improving, designing, and optimizing more complex tests, analyzing results, providing recommendations, and developing reports based on engineering principles that translate to innovative products * Support project teams to optimize device design and performance by utilizing design tools and predictive engineering methods (e.g., CAD, FEA, and optimization) * Analyze and evaluate experimental data to create and validate the computational models * Present the analysis results to the stakeholders and contribute to publishing internal reports and technical summaries * Proactively identify issues, achieve resolution, and resolve problems of significant complexity in designing parts, components, and subsystems * Work in a cross-functional team environment and collaborate with R&D, Regulatory, Quality, Manufacturing, and Supply Chain to meet project objectives * Some domestic and international travel (up to 5%) What you'll need (Required): * Bachelor's Degree in Engineering or Scientific field with minimum of 6 years of experience, including either industry or industry/education -OR- Master's Degree or equivalent in Engineering or Scientific field with minimum of 5 years of experience, including either industry or industry/education -OR- Ph.D. or equivalent in Engineering or Scientific field with minimum of 2 years of experience of experience, including either industry or industry/education * Experience with FE modeling * Experience with FE software (ABAQUS or LS-DYNA) * Experience with CAD software (e.g., SolidWorks or Creo) * Experience with nonlinear mechanics, Fatigue, and plasticity What else we look for (Preferred): * MS or PhD degree in mechanical engineering is preferred * Understanding of general engineering design principles and a working knowledge of the design of experiments (DOE) and other engineering workflows * Familiarity with the mechanics of soft tissues is a plus * Experience with scripting environments such as Python and MATLAB * Ability to interact professionally with all organizational levels * Ability to manage competing priorities in a fast-paced environment * Strict attention to detail * Excellent documentation and communication skills and interpersonal relationship skills, including high discretion/judgment in decision-making * Knowledge of the cGMP Manufacturing environment within the Medical Device Industry, including knowledge of FDA / TUV guidelines and quality system regulations in general * Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management * Participate and present at meetings with internal and external representatives * Develop peer, cross-functional, and cross-business relationships to maximize best practice sharing and team effectiveness * Ability to work independently without close supervision * Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of the environment and prevention of pollution under their span of influence/control Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $118,000 to $167,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
    $118k-167k yearly Auto-Apply 13d ago
  • Principal R&D Design Engineer

    Edwards Lifesciences 4.6company rating

    Irvine, CA jobs

    Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease. As part of our R&D Engineering team, you will work closely with our Quality and Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients' lives around the world. Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients' quality of life and expand their potential treatment opportunities. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you will make an impact: With a strong emphasis on innovation, our Surgical Structural Heart (SSH) business unit is dedicated to addressing significant unmet needs within the field of cardiac surgery. This position with the Design and Simulation Team offers an opportunity to advance design capabilities within the SSH R&D group, contributing to the improvement of current and emerging technologies and therapies. Primary roles and responsibilities include: Lead in improving, designing, and optimizing more complex tests, analyzing results, providing recommendations, and developing reports based on engineering principles that translate to innovative products Support project teams to optimize device design and performance by utilizing design tools and predictive engineering methods (e.g., CAD, FEA, and optimization) Analyze and evaluate experimental data to create and validate the computational models Present the analysis results to the stakeholders and contribute to publishing internal reports and technical summaries Proactively identify issues, achieve resolution, and resolve problems of significant complexity in designing parts, components, and subsystems Work in a cross-functional team environment and collaborate with R&D, Regulatory, Quality, Manufacturing, and Supply Chain to meet project objectives Some domestic and international travel (up to 5%) What you'll need (Required): Bachelor's Degree in Engineering or Scientific field with minimum of 6 years of experience, including either industry or industry/education -OR- Master's Degree or equivalent in Engineering or Scientific field with minimum of 5 years of experience, including either industry or industry/education -OR- Ph.D. or equivalent in Engineering or Scientific field with minimum of 2 years of experience of experience, including either industry or industry/education Experience with FE modeling Experience with FE software (ABAQUS or LS-DYNA) Experience with CAD software (e.g., SolidWorks or Creo) Experience with nonlinear mechanics, Fatigue, and plasticity What else we look for (Preferred): MS or PhD degree in mechanical engineering is preferred Understanding of general engineering design principles and a working knowledge of the design of experiments (DOE) and other engineering workflows Familiarity with the mechanics of soft tissues is a plus Experience with scripting environments such as Python and MATLAB Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast-paced environment Strict attention to detail Excellent documentation and communication skills and interpersonal relationship skills, including high discretion/judgment in decision-making Knowledge of the cGMP Manufacturing environment within the Medical Device Industry, including knowledge of FDA / TUV guidelines and quality system regulations in general Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management Participate and present at meetings with internal and external representatives Develop peer, cross-functional, and cross-business relationships to maximize best practice sharing and team effectiveness Ability to work independently without close supervision Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of the environment and prevention of pollution under their span of influence/control Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $118,000 to $167,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
    $118k-167k yearly Auto-Apply 11d ago
  • Engineer II, R&D

    Edwards Lifesciences 4.6company rating

    Irvine, CA jobs

    Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease. As part of our R&D Engineering team, you will work closely with our Quality and Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients' lives around the world. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you will make an impact: This is a rare opportunity to join a fast-paced, passionate Delivery System R&D team, within Edwards Lifesciences' Transcatheter Mitral and Tricuspid Therapies group, working on transcatheter replacement therapies to address Tricuspid disease. This team is deeply dedicated to transforming treatment to significantly improve patient lives around the world through valve replacement and we need your talent! This Engineer II role will support the next-generation system qualification and commercialization for a product line that offers a novel, highly efficacious therapy to a broad group of patients in need. With your help, this next-generation team will enable the continued growth of an innovative platform that supports a growing transcatheter tricuspid replacement therapy. Build and evaluate products by developing complex experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop reports, based on engineering principles Evaluate manufacturing and clinical inputs, form technical recommendations, and help influence the design of future device iterations Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers Generate test methods, engineering models and drawings/prototypes, etc., to characterize product and/or process specifications Assign R&D support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback Create/update sophisticated design control documents Other duties assigned by Leadership What you'll need (Required): Bachelor's Degree in Engineering or Scientific field with 2+ years of experience -OR- Master's Degree or equivalent in Engineering or Scientific field with internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education What else we look for (Preferred): Mechanical Engineering degree strongly preferred Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering design, design verification & validation Catheter Manufacturing processing experience Medical device design & development experience Experience with DV&V, OQ/PQ Test method validation experience Experience with statistical techniques CAD experience Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast paced environment Must be able to work in a team environment, including the ability to manage vendors and project stakeholders Ability to build productive internal/external working relationships Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $85,000 to $120,000 in tool (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
    $85k-120k yearly Auto-Apply 2d ago
  • Engineer II, R&D

    Edwards Lifesciences 4.6company rating

    Irvine, CA jobs

    Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease. As part of our R&D Engineering team, you will work closely with our Quality and Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients' lives around the world. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. Edwards Lifesciences is looking for an Engineer II to join the THV Access R&D team to work on a next-generation expandable sheath in support of our Transcatheter Heart Valve Replacement platforms. This role will be support technical design and development throughout the full development cycle from product concept through commercialization, working with a cross-functional team to achieve both clinical and commercial milestones. How you'll make an impact: Support and drive testing of product Support and drive design verification testing Support the technical development of the next-generation Access device, including Design for Manufacturing considerations, through all phase of the Design Control process Work on the development of product and component specifications Cross-functional collaboration with Quality, Manufacturing, Clinical, Regulatory, and Marketing team members Support a long-term strategy for deploying new design solutions within the Access platform; partner with process development team and commercial manufacturing sites to implement new designs Think critically to solve complex technical issues Promote knowledge sharing within the team and across teams/functions What you'll need: A Bachelor's degree in engineering discipline is required; preferably Mechanical, Biomedical Engineering. A minimum of 2 years of experience, medical device experience is preferred. What else we look for: Adequate problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making Basic understanding of statistical techniques Capable of analyzing and solving complex problems through innovative thought and experience Strong verbal/written communication and interpersonal skills Ability to work well independently as well as part of a team Ability to work, excel, and manage competing priorities within a fast paced, dynamic, and constantly changing work environment Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $85,000 to $120,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
    $85k-120k yearly Auto-Apply 3d ago
  • Sr Mechanical Engineer II

    Gilead Sciences 4.5company rating

    Foster City, CA jobs

    At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Key Responsibilities Design & Technical Engineering Lead and review the design of mechanical systems. Review, improve, and interpret engineering drawings, specifications, control sequences, P&IDs, and equipment submittals. Develop, implement, and maintain programs and processes to ensure high-quality design and operations, and compliance with CBC, CFC, CMC, cGMPs, GEPs, and GLPs. Collaborate with Maintenance and Operations to ensure equipment maintenance, safety inspections, analyses, and audits are conducted as specified. Report project status and adhere to established guidelines and policies. Facility Operations & System Ownership Serve as technical owner for major building systems, including: Required systems: HVAC, chilled water, heating hot water, cold rooms, clean rooms, environmental chambers, fire protection, plumbing. Desired systems: RO/DI, WFI, PW, USP water systems, wastewater neutralization, CDA, compressed air, specialty gases, vacuum systems. Provide operational engineering support and act as SME on utility systems. Troubleshoot and perform root-cause analysis for system deviations and failures. Define and implement CAPAs for long-term system reliability. Review facility systems capacity planning and trending. Partner with Facilities Maintenance and Operations for audits, condition assessments, and SOP development. Collaborate on project justification packages for mechanical systems, incorporating ROI, total cost of ownership, reliability, and energy efficiency. Strong knowledge of building automation systems preferred. Construction & Project Management Lead design phase of capital and operational projects from concept through closeout. Coordinate with architects, engineers, contractors, and vendors during design, construction, and commissioning. Oversee field inspections and support punch list closeout. Commissioning & Validation Support start-up activities for construction projects. Develop Cx protocols, URSs, SOPs, IQ/OQ activities, and PQ for mechanical and utility systems. Ensure documentation meets GMP, regulatory, and quality standards. Leadership & Collaboration Mentor and guide junior engineers or direct reports. Manage contractors to ensure safe, compliant, and efficient execution of work. Collaborate with Facilities Maintenance, EH&S, Workspace Design, Product Development, Quality, and Research teams. Basic Qualifications Bachelor's degree in Mechanical Engineering or related field with at least 8 years of mechanical engineering experience in R&D facilities, pharmaceutical, biotech, or other cGMP environments. OR Master's degree in Mechanical Engineering or related field with at least 6 years of mechanical engineering experience in R&D facilities, pharmaceutical, biotech, or other cGMP environments. Proven experience with critical utility systems. Demonstrated proficiency in: Core engineering fundamentals. HVAC (cooling/heat load, airflow balance, pressure cascade, fan curves, duct sizing, static pressure calculations). Hydronics (chilled/hot water system design, pump head calcs, NPSH, pipe sizing). High Purity Water Systems (RODI/WFI - USP quality, sanitization concepts, loop design). Controls and Instrumentation (P&IDs, control logic diagrams, SOOs, PID tuning basics, BMS/PLC integration). Utility capacity modeling. Root cause analysis and troubleshooting. Commissioning, startup, and qualification of mechanical systems. Managing vendors, contractors, or direct reports. Applicable codes and standards (CBC, ASHRAE, NFPA, SMACNA, AMCA, FDA CFR, ISO). Preferred Qualifications Experience with GMP compliance, quality systems, or deviation management. Familiarity with Lean, Six Sigma, or continuous improvement methodologies. Professional Engineering (PE) license or progress toward licensure. Experience with CMMS, BMS/EMS/HMS platforms, and facility monitoring systems. Key Soft Skills Strong communication and presentation skills, including ability to interface with senior leadership. Ability to lead cross-functional teams and manage competing priorities. Strategic problem-solving with a continuous improvement mindset. High degree of ownership, accountability, and independent decision-making. Strong teamwork mindset and adaptability. Job Requirements Job Type: Full-time, On-site (5 days/week) Location: Foster City, CA Physical Requirements: Ability to work on construction sites with PPE, lift up to 25 lbs, climb ladders/stairs, and visually inspect job sites. Travel: The salary range for this position is: $157,590.00 - $203,940.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.
    $157.6k-203.9k yearly Auto-Apply 2d ago
  • Principal Mechanical Engineer Project Manager

    Genentech 4.5company rating

    Mechanical engineer job at Genentech

    Genentech is establishing a new Campus Development Team (CDT) to oversee the implementation of the Campus Vision Plan (CVP) for the South San Francisco campus. This Senior Principal Mechanical Engineer position provides single-point accountability for the successful end-to-end delivery of all Mechanical systems, with a primary focus on the complex laboratory and research environments within the gRED development. This role will also provide expertise for the supporting Vivarium, Utility Plant, and Electrical Distribution Hub as part of the CVP. The Principal Mechanical Engineer works within a large, cross-functional project organization and serves as the primary technical liaison, coordinating the specific mechanical systems (HVAC, plumbing, fire protection, building controls, automation and energy management) and reliability needs of scientific and vivarium user groups into actionable engineering designs. This position is responsible for ensuring all mechanical systems are delivered safely, on schedule, within budget, and to the highest standards of quality, meeting the critical demands of a world-class R&D and animal care facility. The Opportunity Responsibilities: The responsibilities for this position may include, but are not limited to: ● Provides technical leadership and deep subject matter expertise for the mechanical engineering designs supporting gRED research laboratories, specialized vivarium spaces, and associated supporting projects. ● Actively leads the design and planning of HVAC, plumbing, fire protection, building controls, automation and energy management critical to laboratory operations and specialized vivarium environments. ● Coordinates with the Utility Master Plans to ensure that upgrades to critical mechanical infrastructure (including the Regional Utility Plant and Electrical Distribution Hub) directly support the reliability, redundancy and scalability required by the new lab facilities. ● Serves as a respected industry expert on laboratory mechanical design, engaging with the Roche/Genentech internal and industry external network to learn, influence, and collaborate on new technologies and best practices for gRED. ● Primary focus will be ensuring scientific user requirements are incorporated into robust technical solutions for the gRED project. ● Provide expert design guidance on HVAC, plumbing, fire protection, building controls, automation and energy management to labs and strategies for flexible 'plug-and-play' capabilities, and robust back-up systems to protect critical experiments, data, and animal life-support systems. ● Work closely with other technical leads to ensure seamless integration of HVAC, plumbing, fire protection, building controls, automation and energy management systems with lab-specific platforms like Building Automation Systems (BAS) and environmental monitoring systems. ● Serve as the mechanical SME in all design and user-group meetings, providing clear technical options analysis and advocating for designs that prioritize scientific workflow, flexibility, and safety. ● A key function of this role will also be to ensure all mechanical designs align with Roche/Genentech and site-specific standards, with a particular focus on standards governing laboratory design and vivarium operations. ● Coordinates the mechanical scope into a comprehensive strategy to address the technical needs across all aspects of the gRED project, from main infrastructure to the point-of-use in the lab. ● A portion of the Principal Mechanical Engineer's time will be spent supporting broad Design Engineering & Construction Services process improvement projects and LEAN initiatives, applying these principles to improve the lab design and delivery process. ● The Senior Principal Mechanical Engineer will be responsible for driving innovation in mechanical systems specifically for R&D environments, adopting technologies that improve lab flexibility, energy efficiency, and operational reliability. ● This role will participate in the development of a project-wide mechanical infrastructure strategy, in partnership with the Design team, to ensure the new gRED labs are adaptable for future scientific platforms and technologies, reducing total cost of ownership while maximizing uptime and research continuity. ● A key portion of the role is continuous learning, engagement with the Roche engineering network (technical experts within the Roche Global organization and other Roche sites) as well as outside industry organizations, including ASHRAE, ISPE and others. Key Tasks: ● Project Planning and Coordination: Develop and maintain a comprehensive project plan, coordinating with architects, engineers, and contractors. Apply innovative thinking to proactively identify and mitigate risks, while monitoring progress via KPIs and reporting status to senior management. ● Budgeting and Resource Management: Support the development and management of the project budget, ensuring cost control and effective resource allocation. This role also supports all procurement activities, including vendor selection, contract negotiation, and material acquisitions. ● Stakeholder Management: Build and maintain strong relationships with internal and external stakeholders, fostering collaboration, transparency, and alignment. Serve as a trusted liaison, keeping all parties informed and engaged through regular meetings and progress reports. ● Team Leadership: Provide effective leadership by clarifying roles and fostering a collaborative, motivated work environment. Mentor and guide team members while also contributing strategic design and technical expertise to the facility's construction. ● Quality Control: Implement and enforce strict quality control measures to ensure compliance with industry standards and specifications.. Who You Are Requirements: ● Bachelor's degree in Mechanical Engineering or equivalent. ● 15 years or more pharmaceutical technology experience in industry or academia after receiving their Bachelor's Degree, at least 8 of which involved mechanical system design, construction and\or commissioning and qualification activities. ● Working knowledge of ANSI / ASHRAE, NEMA, NFPA, EPA, and OSHA standards as well as relevant chemical industry specific standards and documentation (piping and instrumentation diagrams, process flow diagrams). ● Pharmaceutical GMP project mechanical design experience, LEED certification, experience in project management, LEAN / Six Sigma certification, and/or experience working in a campus environment highly desired, but not required. ● Must have excellent communication (written/verbal), presentation, leadership, interpersonal, collaborative, conflict resolution, and negotiating skills ● Excellent organization and planning skills. ● Advanced Microsoft Office and Google Suite skills. ● Exceptional teamwork and collaboration skills are essential to facilitate the work of cross-functional and interdepartmental teams. ● Must be dependable, provide attention to details, and execute proficiently in coordination tasks. ● Self-starter and ability to work with minimum or no supervision. Relocation benefits are not available for this posting. The expected salary range for this position based on the primary location of California is $168,10000 - $312,300 USD Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $168.1k-312.3k yearly 13d ago
  • Senior Principal Mechanical Engineer, Site Services

    Genentech 4.5company rating

    Mechanical engineer job at Genentech

    As a Senior Principal Mechanical Engineer at Genentech, you'll have the unique opportunity to lead the charge in designing and upgrading advanced mechanical systems for a dynamic and evolving portfolio of facilities spanning over 6 million square feet across South San Francisco, Dixon, and beyond. Acting as a technical authority, you'll drive innovative and efficient solutions for critical mechanical infrastructure, utilities, and HVAC systems that underpin Genentech's cutting-edge operations. Collaborating with cross-functional teams and industry leaders, you'll play a strategic role in shaping site standards, ensuring alignment with emerging technologies, regulatory requirements, and corporate excellence. If you're a seasoned engineer with a passion for innovation, collaboration, and pushing industry boundaries, this pivotal role offers the chance to make a lasting impact across a globally recognized organization. The OpportunityResponsibilities: The responsibilities for this position may include, but are not limited to: Under the direction of the Director of Design Engineering, the Design Engineering Senior Principal Mechanical Engineer provides technical leadership and accountability for mechanical engineering designs on capital projects and engineering services done at the South San Francisco, Dixon sites and other sites as requested. This role engages actively in the design and planning of upgrades to critical mechanical infrastructure, utilities and facility HVAC systems across a portfolio of 50+ buildings / ~6M square feet of space. This role is a respected industry expert and engages with the Roche internal and industry external network to learn, influence and collaborate on new technologies, best practices and standards, bringing this knowledge and expertise to bear so that project designs provide safe, efficient and reliable operations to Genentech customers. Project Technical Analysis & Design Guidance: The primary area of focus for this role will be supporting the execution of a portfolio of projects with technical input and technical coordination in the mechanical engineering area, including design guidance on HVAC, plumbing, fire protection, building controls, automation and energy management. The Senior Principal Mechanical Engineer will be assigned 2 - 3 large scale projects ($10M and above) and a portfolio of approximately ~20 projects at a time (ranging in size from $50K to $10M each) for which they will attend key design meetings and provide design input and technical options analysis. The projects will be executed by multi-disciplinary teams, and this role will need to align, coordinate input and influence key customers (R&D, Commercial, Pharmaceutical Technical Operations) and stakeholders (Site Operations, SHE and Security) on project designs. Project Technical Analysis & Design Guidance, continued: The Senior Principal Mechanical Engineer will also provide management and oversight of other Mechanical SMEs brought in as required to manage influx of mechanical related work. A key function of this role will also be to align the many project designs to Roche / Genentech and site specific standards, and to coordinate the scope done on these many small projects into a comprehensive strategy to address needs in this technical area across the site. Lead Mechanical Design Standard Team: SSF Design and Construction executes the design work on portfolio (less than $10M) projects using the services of three alliance engineering firms, each of whom has an assigned mechanical engineering lead. The role will lead a mechanical engineering design sub-team including the representatives of each of these three firms, along with representatives of Site Operations, Environment, Health and Safety (EH&S), and others. As defined by project needs, this team will be tasked with developing strategies for upgrading deficient areas of the campus through the project portfolio. This team may also engage in the development and review of design standards. Site Specific Standards: This role will be responsible for developing site specific mechanical design standards. Such standards will be based on Roche/Genentech corporate standards (including corporate “K” directives), but will be customized for the South San Francisco and Dixon sites. Development of site standards will involve effectively engaging, involving and influencing site leaders, site operations and customer groups, and will involve incorporating new industry technologies and concepts to advance the mechanical infrastructure of the site. Standards will be updated on a schedule agreed with management, and likely driven by upcoming portfolios of projects in a technical area for which such standards apply. This role will also be responsible for maintaining updated standards in an accessible online portal available to partner design firms and stakeholders. Technical Leadership & Industry\Network Engagement: The Senior Principal Mechanical Engineer will be the SSF site expert on industry HVAC/Plumbing, BAS trends and new technologies. As such, a key portion of the role is continuous learning, engagement with the Roche Engineering Network (technical experts within the Roche Global organization and other Roche sites) as well as outside industry organizations, including ASHRAE, ISPE and others. A portion of the role's time will be spent visiting other sites, attending (and occasionally presenting) at applicable conferences and industry events, and applying learned skills to the execution of projects at the SSF site. Technical Leadership & Industry\Network Engagement, continued: Additionally, a portion of the Senior Principal Mechanical Engineer's time will be spent supporting broad Design Engineering process improvement projects and LEAN initiatives, to improve the processes and functioning of the overall team. Strategic Partnership & Innovation: The Senior Principal Mechanical Engineer will be responsible for driving innovation across the design and construction of building systems, appropriately adopting technologies and delivery approaches which improve building systems performance, cost effectiveness, and reliability. This role will lead the development of a site-wide mechanical/electrical infrastructure strategy in partnership with Site Ops and Real Estate & Assets focusing on reducing total cost of ownership, improving performance, and ensuring current site needs are fully met while remaining adaptable to future demands. Additionally, for projects over $10M the role will work with internal and external partners to create and maintain a quality assurance and control program. This includes developing individual and team capabilities, collaborating with external partners to ensure qualified engineering resources are assigned to Genentech projects, and driving change when performance does not meet expectations. The Senior Principal Mechanical Engineer will also be the SSF site expert on industry trends and new technologies for performance-based commissioning and data analytics. Who You Are Requirements: Bachelor's degree in Mechanical Engineering or equivalent. 15 years or more pharmaceutical technology experience in industry or academia after receiving their Bachelor's Degree, at least 8 of which involved mechanical system design, construction and\or commissioning and qualification activities. Working knowledge of ANSI / ASHRAE, NEMA, NFPA, EPA, and OSHA standards as well as relevant chemical industry specific standards and documentation (piping and instrumentation diagrams, process flow diagrams). Pharmaceutical GMP project mechanical design experience, LEED certification, experience in project management, LEAN / Six Sigma certification, and/or experience working in a campus environment highly desired, but not required. Must have excellent communication (written/verbal), presentation, leadership, interpersonal, collaborative, conflict resolution, and negotiating skills Excellent organization and planning skills. Advanced Microsoft Office and Google Suite skills. Exceptional teamwork and collaboration skills are essential to facilitate the work of cross-functional and interdepartmental teams. Must be dependable, provide attention to details, and execute proficiently in coordination tasks. Self-starter and ability to work with minimum or no supervision. Relocation benefits are not available for this position. The expected salary range for this position based on the primary location of California is $159,000.00 - $295,200.00 USD Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $159k-295.2k yearly Auto-Apply 60d+ ago
  • Staff Mechanical Engineer - R&D Robotics

    Johnson & Johnson 4.7company rating

    Santa Clara, CA jobs

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: R&D Product Development Job Sub Function: R&D Mechanical Engineering Job Category: Scientific/Technology All Job Posting Locations: Santa Clara, California, United States of America Job Description: Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of MedTech surgery? Ready to join a team that's reimagining how we heal? Our MedTech Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world's most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech. Job Summary: What We Do: The Strategic Robotics R&D team envisions a future for robotic intervention that is targeted, minimally invasive, and personalized. Building upon a deep understanding of patient and physician needs, we are developing a platform for the next evolution of soft-tissue robotic care. Who We Are: We are a team of mechanical, electrical, mechatronics, robotic controls, software, and clinical engineers who are passionate about improving patient care. The team includes a wide range of experience levels, from junior engineers to industry experts. We follow an iterative design approach to product development that requires us to collaborate closely across clinical, capital hardware, and instruments & accessories teams. We value autonomy and empower each other to take action while remaining a supportive and closely knit team. We take pride in our culture and are committed to building an environment that is inclusive and promotes diversity of thought through varied experiences and backgrounds. You: As a member of the Strategic Robotics R&D team, you will join us on our journey to design and build one of the world's most advanced medical robotic platforms. You will work in coordination with technical experts of multiple robotic platforms to make significant contributions in instrument and accessories design and development, develop clinically relevant solutions, user experience, and more. This role offers a high degree of autonomy and opportunities for growth within the team as we progress towards realizing our vision. We are searching for the best talent for a Staff Mechanical Engineer position, to be located in Santa Clara, CA (On-Site). Performance Objectives and Responsibilities: * Design and develop single and multi-use instruments and accessories for robotically assisted surgeries. * Provide engineering knowledge to ensure feasibility, repeatability, and robustness of proposed designs and tests. * Develop novel technologies for human-robot interaction by closely collaborating with software engineers, robotics engineers, clinical engineers, and physicians. * Iterate quickly on proof-of-concept prototypes, implement long term commercial design solutions, and engage with vendors. * Participate in multi-functional discussions and design reviews. * Participate in clinical procedures and activities related to procedural development. * Mentor and provide engineering guidance to varying levels of mechanical engineers. Required Experience and Skills: * Bachelor's degree in Mechanical Engineering or similar Engineering field with a minimum of 8+ years of experience in medical device design (or PhD with 3+ years, or Master's degree with 6+ years of relevant experience). * Demonstrated experience in mechanism and product design, including the assembly and testing of early R&D prototypes through feature-complete devices. * Demonstrated understanding of materials and how to apply this knowledge to component design. * Demonstrated knowledge of component manufacturing processes (including rapid prototyping, machining, injection molding, metal injection molding, extrusion, etc.). * Possess deep knowledge of mechanical engineering fundamentals (e.g. statics, dynamics, strength of materials, fatigue, FEA, GD&T). * Experience in Design Verification & Validation and Test Method development. * Experience using SolidWorks (or equivalent CAD package), including the ability to create models, assemblies, and detailed drawings, following best design practices and ASME standards. Preferred: * Experience in designing medical instruments and accessories used in conjunction with a robotic platform. Other: * Willingness and ability to travel up to 5% domestically and internationally. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Employees are eligible for the following time off benefits: * Vacation - up to 120 hours per calendar year * Sick time - up to 40 hours per calendar year * Holiday pay, including Floating Holidays - up to 13 days per calendar year * Work, Personal and Family Time - up to 40 hours per calendar year For additional general information on Company benefits, please go to: ********************************************* This job posting is anticipated to close on 01/05/25. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Design Verification Testing, Medical Devices, Medical Instruments, Product Design, Product Manufacturing Preferred Skills: Geometric Dimensioning And Tolerancing (GD&T), Injection Moldings, Process Manufacturing, Prototyping, Rapid Prototyping, Surgical Instruments The anticipated base pay range for this position is : The anticipated base pay range for this position is $134,000.00 to $231,150.00 Additional Description for Pay Transparency:
    $134k-231.2k yearly Auto-Apply 11d ago
  • Staff Mechanical Engineer - R&D Robotics

    J&J Family of Companies 4.7company rating

    Santa Clara, CA jobs

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* **Job Function:** R&D Product Development **Job Sub** **Function:** R&D Mechanical Engineering **Job Category:** Scientific/Technology **All Job Posting Locations:** Santa Clara, California, United States of America **Job Description:** Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of MedTech surgery? Ready to join a team that's reimagining how we heal? Our MedTech Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world's most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech . **Job Summary:** **What We Do:** The Strategic Robotics R&D team envisions a future for robotic intervention that is targeted, minimally invasive, and personalized. Building upon a deep understanding of patient and physician needs, we are developing a platform for the next evolution of soft-tissue robotic care. **Who We Are:** We are a team of mechanical, electrical, mechatronics, robotic controls, software, and clinical engineers who are passionate about improving patient care. The team includes a wide range of experience levels, from junior engineers to industry experts. We follow an iterative design approach to product development that requires us to collaborate closely across clinical, capital hardware, and instruments & accessories teams. We value autonomy and empower each other to take action while remaining a supportive and closely knit team. We take pride in our culture and are committed to building an environment that is inclusive and promotes diversity of thought through varied experiences and backgrounds. **You:** As a member of the Strategic Robotics R&D team, you will join us on our journey to design and build one of the world's most advanced medical robotic platforms. You will work in coordination with technical experts of multiple robotic platforms to make significant contributions in instrument and accessories design and development, develop clinically relevant solutions, user experience, and more. This role offers a high degree of autonomy and opportunities for growth within the team as we progress towards realizing our vision. **We are searching for the best talent for a Staff Mechanical Engineer position, to be located in Santa Clara, CA (On-Site).** **Performance Objectives and Responsibilities:** + Design and develop single and multi-use instruments and accessories for robotically assisted surgeries. + Provide engineering knowledge to ensure feasibility, repeatability, and robustness of proposed designs and tests. + Develop novel technologies for human-robot interaction by closely collaborating with software engineers, robotics engineers, clinical engineers, and physicians. + Iterate quickly on proof-of-concept prototypes, implement long term commercial design solutions, and engage with vendors. + Participate in multi-functional discussions and design reviews. + Participate in clinical procedures and activities related to procedural development. + Mentor and provide engineering guidance to varying levels of mechanical engineers. **Required Experience and Skills:** + Bachelor's degree in Mechanical Engineering or similar Engineering field with a minimum of 8+ years of experience in medical device design (or PhD with 3+ years, or Master's degree with 6+ years of relevant experience). + Demonstrated experience in mechanism and product design, including the assembly and testing of early R&D prototypes through feature-complete devices. + Demonstrated understanding of materials and how to apply this knowledge to component design. + Demonstrated knowledge of component manufacturing processes (including rapid prototyping, machining, injection molding, metal injection molding, extrusion, etc.). + Possess deep knowledge of mechanical engineering fundamentals (e.g. statics, dynamics, strength of materials, fatigue, FEA, GD&T). + Experience in Design Verification & Validation and Test Method development. + Experience using SolidWorks (or equivalent CAD package), including the ability to create models, assemblies, and detailed drawings, following best design practices and ASME standards. **Preferred:** + Experience in designing medical instruments and accessories used in conjunction with a robotic platform. **Other:** + Willingness and ability to travel up to 5% domestically and internationally. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Employees are eligible for the following time off benefits: + Vacation - up to 120 hours per calendar year + Sick time - up to 40 hours per calendar year + Holiday pay, including Floating Holidays - up to 13 days per calendar year + Work, Personal and Family Time - up to 40 hours per calendar year For additional general information on Company benefits, please go to: ********************************************* This job posting is anticipated to close on 01/05/25. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource. **Required Skills:** Design Verification Testing, Medical Devices, Medical Instruments, Product Design, Product Manufacturing **Preferred Skills:** Geometric Dimensioning And Tolerancing (GD&T), Injection Moldings, Process Manufacturing, Prototyping, Rapid Prototyping, Surgical Instruments **The anticipated base pay range for this position is :** The anticipated base pay range for this position is $134,000.00 to $231,150.00 Additional Description for Pay Transparency:
    $134k-231.2k yearly 60d+ ago
  • Facilities Engineer 2

    Illumina 4.8company rating

    San Diego, CA jobs

    What if the work you did every day could impact the lives of people you know? Or all of humanity? At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients. Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible. The Facilities Engineer 2 will be part of the San Diego Facilities Engineering & Maintenance (FEM) team. This role will be responsible for providing technical expertise as related to mechanical systems within facilities equipment engineering, support maintenance, and/or calibration and equipment performance optimization. Including projects related to mechanical, electrical, and plumbing (MEP) systems in an FDA regulated environment. The individual will possess technical knowledge of facilities water purification (RO/DI) skids, HVAC, Chillers, Cooling Towers, Boilers, centralized gas distribution systems, walk-in cold storage units, clean rooms, BMS/EMS system, Electrical generation and distribution system and other plant utilities, facilities validation, as well as construction management skills. Responsibilities: * Ability to serve a variety of facilities equipment supporting manufacturing, critical business functions and administrative areas. * Provides direct input into the CMMS, SAP/EAM, to ensure health of the asset throughout the lifecycle. Examples of input include onboarding equipment, uploading maintenance plans, task lists and key calibration parameters. * Work closely with maintenance mechanics assisting in complex equipment breakdowns. Provides direct input to Siemens Desigo BMS/EMS system * Inspects all work to assure compliance with plans and specifications. Ensures project documents are complete, current, and stored appropriately. * Provide reports and presentations on proposed projects and policies. * Maintain reliability systems and programs to improve uptime. * Track and analyze historical data of operations and KPIs. * Provide input for continuous improvement in the areas of facilities and engineering. * Provide input and author SOP, WI, Commissioning, Validation Protocols, Deviations, CAPAs and other cGMP documentation. * Generation of specifications and other engineering documents as used for equipment design and qualification. * Provide input on procedures for equipment maintenance and calibration. * Analysis of equipment metrics to support continuous improvement efforts. * Support of engineering change control for new equipment design and modification. * Creation of impact assessments for equipment changes. * Support of internal processes to ensure regulatory compliance is maintained. * Cross-functional collaboration to complete projects and solve problems. * Strong communication skills and the ability to interact with cross-functional groups at all levels. * Ability to manage competing priorities and maintain tight timelines * Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs. Requirements: * Typically Requires a minimum of 2 years of related experience with a bachelor's degree or technical schooling; or 1 year and a master's degree; or equivalent work experience in Industrial Engineering, Mechanical Engineering, Electrical Engineering or HVAC/Controls. * 2-5 years experience with Equipment/Facilities Engineering, with design and/or maintenance focus * Knowledge with Siemens BMS Desigo CC Master Operator, HMI is preferred * Completed facilities management coursework in a technical or trade school, such as HVAC or plumbing, active industry facilities management association members is preferred * Familiarity with related quality standards (ISO 13485, 21 CFR 820, etc.) for implementation and review. * Understanding of a risk-based approach to Commissioning, Qualification and Validation (CQV) of Facilities, Utilities and Equipment (FUE) in a medical device and/or drug GMP environment Experience working cross-functionally to develop technical requirements * Experience in clean rooms, RODI, HVAC/Controls, Boilers, pumps, cooling towers, chillers and other systems used to support a regulated manufacturing environment * Experience creating master validation plans, protocols, and reports * Experience with Siemens building automated programs such as Insight or Desigo is preferred * Must be well-versed with Microsoft Office products such as Word, Excel, and Outlook Must be able to read construction drawings and blueprints * Familiar with AutoCAD, Revit, and Bluebeam * Familiar with CMMS, like SAP/EAM, Maximo, The estimated base salary range for the Facilities Engineer 2 role based in the United States of America is: $73,400 - $110,200. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual's qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off. We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: ****************************************************************** The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.
    $73.4k-110.2k yearly Auto-Apply 13d ago
  • Engineering Project Feasibility and Product Sourcing Leader

    Genentech 4.5company rating

    Mechanical engineer job at Genentech

    Doing now what patients need next… for a healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche. This role is based in Pharma Technical Operations Technology (PTT), an organization that is responsible for ensuring Pharma Technical Operations (PT) stays at the forefront of technology in our current and future facilities. PTT, composed of global MSAT and Engineering, plays a key role in leading seamless industrialization and thorough technical product management through integrating SHE, proactive maintenance, facility fitness, performance optimization, and scalable manufacturing processes and technologies in support of the manufacturing network. In this role, you will have the opportunity to shape the manufacturing network that delivers life saving medicines to patients. The Opportunity The Engineering Project Feasibility and Product Sourcing Leader within the PTT Asset Health & Future Assets (AHFA) group conducts early feasibility and product sourcing assessments for Global Engineering CapEx projects. This role ensures that capital investments and investments supporting sourcing decisions align with and enable the Pharma long-range plan. A core responsibility of this role is partnering closely with Network Strategy, Global Product & Supply Chain Management, manufacturing sites, and Finance to develop robust business cases that inform PT governance decisions regarding capital investments and product sourcings. * Secures buy-in from stakeholders and senior leadership, drives cross-functional alignment, and resolves issues within the engineering community and broader network for Global Engineering CapEx projects * Builds robust scenarios that model best- and worst-case outcomes and provide flexibility for informed decision-making in a dynamic business environment * Develops comprehensive business cases for capital projects, maintaining fiduciary responsibility for real estate and equipment assets * Assesses requirements for product launches, technology transfers, and capital investments; ensures assumptions across options are agreed upon and aligned with stakeholders * Conducts complex early feasibility assessments across sites and functions, collaborating closely with senior leaders, subject matter experts, and site engineering teams * Partners with the engineering community/network to apply technology standards that enable successful project outcomes and reduce business risk * Transitions completed early feasibility assessments to Project Initiation teams and contributes as an expert reviewer during project reviews Who You Are * Bachelor's degree in Engineering or related field * Minimum of 12 years of Pharmaceutical or Biotech experience, process engineering experience preferred * Minimum of 8 years of management leadership experience in a matrix organization * Experience in a complex global environment with CapEx project execution * International/global experience is strongly preferred * Flexibility for domestic and international travel as required Relocation benefits are not available for this posting. The expected salary range for this position based on the primary location of South San Francisco, California is $156,700 to $290,900. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits #LI-PK1 Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $156.7k-290.9k yearly 2d ago
  • Engineering Project Feasibility and Product Sourcing Leader

    Genentech 4.5company rating

    Mechanical engineer job at Genentech

    Doing now what patients need next… for a healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche. This role is based in Pharma Technical Operations Technology (PTT), an organization that is responsible for ensuring Pharma Technical Operations (PT) stays at the forefront of technology in our current and future facilities. PTT, composed of global MSAT and Engineering, plays a key role in leading seamless industrialization and thorough technical product management through integrating SHE, proactive maintenance, facility fitness, performance optimization, and scalable manufacturing processes and technologies in support of the manufacturing network. In this role, you will have the opportunity to shape the manufacturing network that delivers life saving medicines to patients. The Opportunity The Engineering Project Feasibility and Product Sourcing Leader within the PTT Asset Health & Future Assets (AHFA) group conducts early feasibility and product sourcing assessments for Global Engineering CapEx projects. This role ensures that capital investments and investments supporting sourcing decisions align with and enable the Pharma long-range plan. A core responsibility of this role is partnering closely with Network Strategy, Global Product & Supply Chain Management, manufacturing sites, and Finance to develop robust business cases that inform PT governance decisions regarding capital investments and product sourcings. Secures buy-in from stakeholders and senior leadership, drives cross-functional alignment, and resolves issues within the engineering community and broader network for Global Engineering CapEx projects Builds robust scenarios that model best- and worst-case outcomes and provide flexibility for informed decision-making in a dynamic business environment Develops comprehensive business cases for capital projects, maintaining fiduciary responsibility for real estate and equipment assets Assesses requirements for product launches, technology transfers, and capital investments; ensures assumptions across options are agreed upon and aligned with stakeholders Conducts complex early feasibility assessments across sites and functions, collaborating closely with senior leaders, subject matter experts, and site engineering teams Partners with the engineering community/network to apply technology standards that enable successful project outcomes and reduce business risk Transitions completed early feasibility assessments to Project Initiation teams and contributes as an expert reviewer during project reviews Who You Are Bachelor's degree in Engineering or related field Minimum of 12 years of Pharmaceutical or Biotech experience, process engineering experience preferred Minimum of 8 years of management leadership experience in a matrix organization Experience in a complex global environment with CapEx project execution International/global experience is strongly preferred Flexibility for domestic and international travel as required Relocation benefits are not available for this posting. The expected salary range for this position based on the primary location of South San Francisco, California is $156,700 to $290,900. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits #LI-PK1 Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $156.7k-290.9k yearly Auto-Apply 23d ago
  • Engineering Project Feasibility and Product Sourcing Leader

    Genentech 4.5company rating

    Mechanical engineer job at Genentech

    ** Doing now what patients need next... for a healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche. This role is based in Pharma Technical Operations Technology (PTT), an organization that is responsible for ensuring Pharma Technical Operations (PT) stays at the forefront of technology in our current and future facilities. PTT, composed of global MSAT and Engineering, plays a key role in leading seamless industrialization and thorough technical product management through integrating SHE, proactive maintenance, facility fitness, performance optimization, and scalable manufacturing processes and technologies in support of the manufacturing network. In this role, you will have the opportunity to shape the manufacturing network that delivers life saving medicines to patients. **The Opportunity** The Engineering Project Feasibility and Product Sourcing Leader within the PTT Asset Health & Future Assets (AHFA) group conducts early feasibility and product sourcing assessments for Global Engineering CapEx projects. This role ensures that capital investments and investments supporting sourcing decisions align with and enable the Pharma long-range plan. A core responsibility of this role is partnering closely with Network Strategy, Global Product & Supply Chain Management, manufacturing sites, and Finance to develop robust business cases that inform PT governance decisions regarding capital investments and product sourcings. + Secures buy-in from stakeholders and senior leadership, drives cross-functional alignment, and resolves issues within the engineering community and broader network for Global Engineering CapEx projects + Builds robust scenarios that model best- and worst-case outcomes and provide flexibility for informed decision-making in a dynamic business environment + Develops comprehensive business cases for capital projects, maintaining fiduciary responsibility for real estate and equipment assets + Assesses requirements for product launches, technology transfers, and capital investments; ensures assumptions across options are agreed upon and aligned with stakeholders + Conducts complex early feasibility assessments across sites and functions, collaborating closely with senior leaders, subject matter experts, and site engineering teams + Partners with the engineering community/network to apply technology standards that enable successful project outcomes and reduce business risk + Transitions completed early feasibility assessments to Project Initiation teams and contributes as an expert reviewer during project reviews **Who You Are** + Bachelor's degree in Engineering or related field + Minimum of 12 years of Pharmaceutical or Biotech experience, process engineering experience preferred + Minimum of 8 years of management leadership experience in a matrix organization + Experience in a complex global environment with CapEx project execution + International/global experience is strongly preferred + Flexibility for domestic and international travel as required Relocation benefits are not available for this posting. The expected salary range for this position based on the primary location of South San Francisco, California is $156,700 to $290,900. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits (**************************************************** \#LI-PK1 Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (***************************************************************************************************** .
    $156.7k-290.9k yearly 20d ago
  • Sr Engineer 1, Facilities & Utilities

    Biomarin Pharmaceutical 4.6company rating

    San Rafael, CA jobs

    Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Corporate Groups It takes a village, and at BioMarin our corporate groups are the people behind our success. Groups such as IT, Finance, Legal, Global Compliance & Ethics, and our People Team provide foundational support of all areas of operation at BioMarin. Job Title: Sr. Engineer 1, Facilities & UtilitiesLocation: San Rafael, California Reports To: Associate Director Site Operations SUMMARY DESCRIPTIONThe Site Operations, Facilities & Engineering Group provides technical support, guidance, and strategic vision to ensure that the facilities, utilities, warehouse, and laboratory equipment for BioMarin's domestic operations are designed, operated, and maintained in a manner consistent with regulatory agencies, environmental health & safety and asset lifecycle management best practices. This role will manage external vendors and contractors within a site-based Facilities & Engineering team dedicated to supporting operations across Northern California locations. Reporting to the Associate Director Site Operations you will work closely with REWS, California Facilities & Engineering, Procurement and Laboratory Operations. This role enables the teams at Biomarin to focus on its patient-centered mission, delivering first-in-class and best-in-class therapeutics that provide meaningful advances for those with serious and life-threatening rare genetic diseases. The engineer will be responsible for ongoing support to non-GxP site operations across Northern California campuses to ensure utilities, facilities and equipment performs per its intended use and function. The engineer will be responsible for supporting the design, engineering, and commissioning of new or modified utility systems, as well as non-GxP facilities, laboratory spaces, and administrative office buildings. The engineer will be responsible for supporting the project portfolio of operational expenditure (Opex) and capital expenditure (Capex) projects at each campus, providing facility engineering and equipment advisement, participating in asset lifecycle management (ALM), facility long range planning, and initiating team improvement projects. The engineer will: Interact collaboratively with key customers, peers, and other stakeholders to support achieving BioMarin tactical and strategic goals & objectives. Highlight and submit improvement and investment projects related to facilities and utilities systems. Work with end users to develop system requirements, specification of equipment/buildings, review design from outside engineering firms or contractors (as needed). Participate in long-term strategic development of site utility system, facilities and energy efficiency programs. May be requested to support other opportunities as directed by management. Work closely with other support groups such as Maintenance, Metrology, Automation, Capital Projects, EHS&S, Facilities, Laboratory Operations and Security to assure that BioMarin assets are well managed throughout their lifecycle. Provide coaching, mentoring and guidance for junior engineers and may be designated as a subject matter expert for one or more clean/dirty utility systems. RESPONSIBILITIES Represent the Engineering, Facilities and Services department, collaborate, and provide advisement on non-GMP facility, utility, and equipment capital projects for Northern California campuses. Monitor and report on the status of the non-GxP campus goals and objectives to ensure they are aligned with BioMarin enterprise strategy. Provide Engineering support of non-GxP laboratories and their associated Facilities/Utilities systems. Act as the Facilities Engineering resource on cross-functional project teams. Collaborate, monitor, and evaluate the asset lifecycle management of non-GMP related facility systems, utility systems and equipment, assess failure risks and asset replacement planning activities. Consult on the long-range planning to ensure asset replacement is scheduled and budgeted to ensure the continuity and availability of business facilities. Partner with EHS&S to support the emergency response team to ensure business continuity and ensure all BioMarin safety policies, procedures, standards, and practices are followed. Successfully plan, execute, and deliver ad-hoc requests, tasks and activities as needed from end users and customers. Demonstrate leadership ability including the ability to lead, motivate, develop, and directly/indirectly manage others effectively. Advance safety, health, and environmental stewardship at BioMarin through technical decisions, guidance, and leadership. Effectively manage internal and external relationships with customers, key stakeholders, and vendors. Demonstrate the ability to be self-directed with limited guidance and oversight from management. Support and drive the development of internal engineering practices and procedures. Effectively apply independent judgment utilizing BioMarin policies, industry practices and BioMarin standards as guidance. Actively participate in technical, tactical, and strategic reviews/discussions. Remain current on all training requirements. Demonstrate the ability to plan and implement small projects. Identify and champion projects and continuous improvement (CI) initiatives that will successfully support BioMarin business goals and objectives. Stay current with leading edge technologies, alternative energy strategies, sustainability trends and best practices through contacts with industry, service/equipment providers, and other formal/informal means. 2 days on site minimum up to 4 days per week presence required with additional time necessary depending on activities. Other duties as assigned. EDUCATIONBS or MS in Chemical, Mechanical, or other Engineering degree from an accredited university. Relevant job and years of experience may be substituted in place of a degree. EXPERIENCE A minimum of 5-7 years' experience in engineering, facilities/lab operations and clean/dirty plant utilities, preferably in the biotechnology or pharmaceutical industry. Highly proficient in deploying, managing, and improving an asset lifecycle management framework, policies, procedures, and practices, conducting equipment risk assessments, maintaining critical asset information, monitoring asset failure history, and recommending asset replacement schedules. Proficient in the relevant aspects of current Good Manufacturing Practices (cGMP), Good Clinical Practices (cGCP) and Good Laboratory Practices (cGLP) Demonstrated successful engineering support of capital projects ranging from $1M to $10M. An understanding and awareness of latest industry standards of environmental sustainability integration to the biopharmaceutical sector (e.g. knowledge of ISO 50001) Demonstrated engineering Subject Matter Expertise (SME) in at least one of the following systems: RO/DI, Clean Dry Air (CDA), clean process gas systems, HVAC, Plant Steam, Chilled water, Condenser Water, Process Wastewater, refrigeration, or electrical systems Strong organization, interpersonal, oral, and written communication skills. Strong analytical and problem solving abilities with strong capability in lab facility related technology. Ability to work in a fast paced, dynamic environment with a high level of Integrity. Proficiency with standard office software applications, including MS Outlook, MS Word, MS Excel, MS Power Point. Proficient in utilizing Purchase Order and Spend Management Systems (e.g., Coupa, SAP, Ariba) Proficiency in creating, editing, and reviewing, engineering/architectural drawings is required. Experience in the use of engineering software tools (e.g. CAD, Bluebeam). BMS JCI MetaSys related experience a plus. WORK ENVIRONMENT / PHYSICAL DEMANDS While primarily a day shift job, hours will vary based on the needs of the position. This position may require additional hours and weekend/holiday work depending upon various facility requirements. Provide after-hours leadership/managerial on-call support as required. While performing the duties of this job the employee is frequently required to stand, walk, sit, talk, or hear, reach with hands and arms, climb stairs or ladders, balance, stoop, kneel, or crouch. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Lead other Engineers from the team as required. Engineers can be assigned to work with the Engineer to support relevant activities in their area. Lead external consultants to complete critical activities and deliver compliant work on schedule and within budget. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
    $118k-145k yearly est. Auto-Apply 16d ago
  • Engineering Project Feasibility and Product Sourcing Leader

    Genentech 4.5company rating

    Mechanical engineer job at Genentech

    Doing now what patients need next… for a healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche. This role is based in Pharma Technical Operations Technology (PTT), an organization that is responsible for ensuring Pharma Technical Operations (PT) stays at the forefront of technology in our current and future facilities. PTT, composed of global MSAT and Engineering, plays a key role in leading seamless industrialization and thorough technical product management through integrating SHE, proactive maintenance, facility fitness, performance optimization, and scalable manufacturing processes and technologies in support of the manufacturing network. In this role, you will have the opportunity to shape the manufacturing network that delivers life saving medicines to patients. The Opportunity The Engineering Project Feasibility and Product Sourcing Leader within the PTT Asset Health & Future Assets (AHFA) group conducts early feasibility and product sourcing assessments for Global Engineering CapEx projects. This role ensures that capital investments and investments supporting sourcing decisions align with and enable the Pharma long-range plan. A core responsibility of this role is partnering closely with Network Strategy, Global Product & Supply Chain Management, manufacturing sites, and Finance to develop robust business cases that inform PT governance decisions regarding capital investments and product sourcings. Secures buy-in from stakeholders and senior leadership, drives cross-functional alignment, and resolves issues within the engineering community and broader network for Global Engineering CapEx projects Builds robust scenarios that model best- and worst-case outcomes and provide flexibility for informed decision-making in a dynamic business environment Develops comprehensive business cases for capital projects, maintaining fiduciary responsibility for real estate and equipment assets Assesses requirements for product launches, technology transfers, and capital investments; ensures assumptions across options are agreed upon and aligned with stakeholders Conducts complex early feasibility assessments across sites and functions, collaborating closely with senior leaders, subject matter experts, and site engineering teams Partners with the engineering community/network to apply technology standards that enable successful project outcomes and reduce business risk Transitions completed early feasibility assessments to Project Initiation teams and contributes as an expert reviewer during project reviews Who You Are Bachelor's degree in Engineering or related field Minimum of 12 years of Pharmaceutical or Biotech experience, process engineering experience preferred Minimum of 8 years of management leadership experience in a matrix organization Experience in a complex global environment with CapEx project execution International/global experience is strongly preferred Flexibility for domestic and international travel as required Relocation benefits are not available for this posting. The expected salary range for this position based on the primary location of South San Francisco, California is $156,700 to $290,900. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits #LI-PK1 Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $156.7k-290.9k yearly Auto-Apply 21d ago
  • Manufacturing Engineer II - Shockwave

    J&J Family of Companies 4.7company rating

    Santa Clara, CA jobs

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* **Job Function:** Supply Chain Engineering **Job Sub** **Function:** Manufacturing Engineering **Job Category:** Scientific/Technology **All Job Posting Locations:** Santa Clara, California, United States of America **:** **Description - External** Johnson & Johnson is hiring for a **Manufacturing Engineer II - Shockwave Medical** to join our team located in **Santa Clara, CA** . At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************/ . Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. **Position Overview** The Manufacturing Engineer II is responsible for providing engineering support to Production. Also responsible for designing, developing, testing, and implementing processes, tooling, and fixtures for commercial product. In addition, the Manufacturing Engineer II will sustain activities on the production line such as raw material, process and equipment issues. **Essential Job Functions** + Actively collaborate with Production to provide sustaining support in resolving product/process/equipment problems. + Actively identify and participate in process/product, tooling, equipment, fixtures and cost reduction improvement projects. + Coordinate and/or perform functional and destructive testing to support Engineering Reports. Document the results and provide a statistical analysis using Minitab or excel. + Participate as an extended team member for new product introduction, including scaling up, stabilizing and transfer to alternate sites. + Participate in development and maintenance of process FMEAs, Manufacturing Process Instructions (MPIs), and Device Master Record (DMR) documents. + Create, maintain and transfer paper Bill of Materials (BOM's) and Lot History Records (LHR's) into Item Structures, Work Definitions and electronic LHR's. + Support efforts to resolve Quality related events (NCR, CAPA, Audit Finding) and maintain other Quality System Requirements. + Create and release label files used for printing product labels. + Create and execute process validation protocols and reports. + Other duties as assigned. These job requirements are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel. **Qualifications - External** + Bachelor's degree in engineering. + 3-5 years of experience in a medical device environment. + Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD, MDR and other applicable regulations. + Understanding of Lean and Six Sigma concepts. + Experience with Validation of Medical Devices (IQ-OQ-PQ). + Basic understanding of Statistics (Cpk, Hypothesis Testing, DOE's, Gage R&R) a plus. + Able to create and maintain Drawings in SolidWorks. + Ability to work in a fast-paced environment while managing multiple priorities. + Operate as a team and/or independently while demonstrating flexibility to changing requirements. + Experience with MES and ERP (Oracle) preferred + Employee may be required to lift objects up to 25lbs or more. + Employee will be required to work in an air-conditioned Class 8 Cleanroom. **Additional Information:** + The anticipated base pay for this position is $73,000.00 to $117,300 annually. + The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. + Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. + Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). + Employees are eligible for the following time off benefits: + Vacation - up to 120 hours per calendar year + Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year + Holiday pay, including Floating Holidays - up to 13 days per calendar year + Work, Personal and Family Time - up to 40 hours per calendar year + Additional information can be found through the link below. ********************************************* The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. _NOTE:_ _This job description is not intended to be all-inclusive. Employee may perform other related duties as assigned or negotiated to meet the ongoing needs of the organization._ _This job posting is anticipated to close on March 11, 2025. The Company may however extend this time-period, in which case the posting will remain available on_ _**************************** _to accept additional applications._ _Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability._ _For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit_ _******************** _._ **The anticipated base pay range for this position is :** Additional Description for Pay Transparency:
    $73k-117.3k yearly 60d+ ago

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