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Laboratory Engineer jobs at Emory Healthcare

- 474 jobs
  • Engineer, High Containment Lab - Campus Services

    Emory Healthcare/Emory University 4.3company rating

    Laboratory engineer job at Emory Healthcare

    **Discover Your Career at Emory University** Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the excellence of our academic community. **Description** JOB DESCRIPTION: + Reporting to the Director of Engineering Services, this position is responsible for engineering oversight of high containment laboratory systems (Biosafety Safety Level 3 and Animal Biosafety Level 3) as well as engineering and controls for Biosafety Level 2 laboratories. + Responsible for evaluation of engineering control systems, coordinating with University entities to assure laboratories are properly maintained, participating in laboratory design review, construction oversight, and commissioning assistance. + Develops a consistent management routine to review the BAS controls graphics and fault detection programs to look for potential disruption in functions. + Reviews and advises FM team related to Preventative Maintenance tasks for each lab. + Reviews completed PMs for adequacy and timeliness. + Tracks repairs of equipment and systems. + Coordinates FM activities related to the annual maintenance shutdown for high containment labs. + Maintains detailed and accurate project records including testing protocols, trend data, and reports. + Works to support rational and beneficial energy conservation in lab HVAC operations. + Collaborates with members of the Emory community including Environmental Health and Safety, School of Medicine, Emory College and Facilities Management staff. + Provides technical assistance to Emory National Primate Center and Emory University Hospital related to labs and ventilation strategies as requested. + Serves on relevant University research related committees including Institutional Biosafety Committee (IBC). + Performs other related duties as required.MINIMUM QUALIFICATIONS: + A bachelor's degree in engineering or lab related science degree from an ABET accredited program and ten years of related work experience. + General knowledge of building codes and state and federal regulations. + Working knowledge of laboratory design and Biosafety in Microbiological and Biomedical Laboratories (BMBL). + Demonstrated ability to multi-task and handle multiple priorities. + Required to wear personal protective equipment where necessary. + A Professional Engineer license in the State of Georgia is preferred. + Prefer active membership of the International Institute for Sustainable Laboratories (I2SL) organization, both Georgia Chapter and National organization NOTE: This role will be granted the opportunity to work from home regularly but must be able to commute to Emory University on a flexible weekly schedule based upon business needs. Schedule is based on agreed upon guidelines of department. This role requires residency in the state of GA. Emory reserves the right to change remote work status with notice to employee. \#LI-VJ1 **Additional Details** Emory is an equal opportunity employer, and qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by state or federal law. Emory University does not discriminate in admissions, educational programs, or employment, including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. Students, faculty, and staff are assured of participation in university programs and in the use of facilities without such discrimination. Emory University complies with Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veteran's Readjustment Assistance Act, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity, and affirmative action (for protected veterans and individuals with disabilities). Inquiries regarding this policy should be directed to the Emory University Department of Equity and Civil Rights Compliance, 201 Dowman Drive, Administration Building, Atlanta, GA 30322. Telephone: ************ (V) | ************ (TDD). Emory University is committed to ensuring equal access and providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to seek a reasonable accommodation, please contact the Department of Accessibility Services at accessibility@emory.edu or call ************ (Voice) | ************ (TDD). We kindly ask that requests be made at least seven business days in advance to allow adequate time for coordination. **Connect With Us!** Connect with us for general consideration! **Job Number** _153017_ **Job Type** _Regular Full-Time_ **Division** _Campus Services_ **Department** _FM Engineering Services_ **Job Category** _Facility Support and Building Maintenance_ **Campus Location (For Posting) : Location** _US-GA-Atlanta_ **_Location : Name_** _Emory Campus-Clifton Corridor_ **Remote Work Classification** _Hybrid Remote_ **Health and Safety Information** _Not Applicable_
    $71k-99k yearly est. 60d+ ago
  • Operational Excellence Engineer II

    Emory Healthcare/Emory University 4.3company rating

    Laboratory engineer job at Emory Healthcare

    **Be inspired. Be rewarded. Belong. At Emory Healthcare.** At Emory Healthcare we fuel your professional journey with better benefits, valuable resources, ongoing mentorship and leadership programs for all types of jobs, and a supportive environment that enables you to reach new heights in your career and be what you want to be. We provide: - Comprehensive health benefits that start day 1 - Student Loan Repayment Assistance & Reimbursement Programs - Family-focused benefits - Wellness incentives - Ongoing mentorship, development, and leadership programs - And more **Work Location:** Atlanta, GA(100% onsite) - This position will support 3 Emory Hospitals in DeKalb County with a primary office at Emory Decatur Hospital. **Description** The **Operational Excellence Engineer** **II** at Emory Healthcare plays a key role in driving continuous improvement initiatives across the organization. This advanced-level position focuses on optimizing healthcare systems, enhancing patient outcomes, and supporting cross-functional teams with process improvement projects. With a solid foundation in Lean and Six Sigma methodologies, the Engineer II independently manages moderate-to-complex projects and serves as a knowledgeable resource on best practices for operational efficiency and quality improvement. + Process Improvement Projects: + Lead and support moderate-to-complex projects to enhance healthcare systems and operational efficiency + Utilize a structured methodology to analyze localized systems and processes, recommend improvements, and coordinate change implementation through individual and team facilitation + Advanced Data Analysis: + Conduct in-depth workflow analyses, time studies, and data collection + Apply statistical techniques to analyze data, create advanced process maps, generate Pareto charts, pivot tables, develop run/control charts to identify trends and opportunities for improvement and establish statistical significance for causal factors + Access eHMR and other databases to modify established reports for analysis + Lean & Six Sigma Facilitation: + Act as a mentor and resource for departments implementing Lean and Six Sigma methodologies + Provide guidance on Daily Management Systems, A3 problem solving, and advanced Lean concepts such as kaizen and value stream mapping + Project Management & Planning: + Independently manage project timelines, resources, and milestones for process improvement initiatives + Collaborate with leadership and stakeholders to define project goals, scope, and deliverables, ensuring alignment with organizational objectives + Productivity & Performance Review: + Conduct comprehensive reviews of departmental productivity and operational performance + Identify root causes of inefficiencies and escalate findings to responsible roles, offering actionable recommendations for improvement + Reporting & Communication: + Develop and present detailed reports, dashboards, and presentations for leadership and department stakeholders + Communicate project progress, challenges, and outcomes effectively to cross-functional teams and executive leadership + Research & Innovation: + Research industry best practices and emerging trends in healthcare operational excellence + Propose innovative solutions and improvements that enhance the effectiveness and sustainability of Emory Healthcare's processes. **MINIMUM QUALIFICATIONS:** + Education: Bachelor's degree in Industrial Engineering, Healthcare Administration, Business, or a related field + Master's degree preferred + Experience: 3-5 years of experience in process improvement, engineering, or operations, preferably in a healthcare environment + Certifications: Lean and/or Six Sigma Green Belt certification preferred. **SKILLS:** + Proficient in Process Improvement methodologies with a demonstrated ability to apply these concepts in complex settings + Strong analytical and statistical skills, with experience in data analysis tools such as Excel, Tableau, Minitab, or similar software + Excellent project management skills with the ability to independently manage multiple projects and prioritize effectively + Advanced communication and interpersonal skills, with experience presenting to leadership and cross-functional teams **COMPENTENCIES:** + Leadership: Demonstrated ability to lead projects and collaborate effectively with cross-functional teams at all organizational levels + Critical Thinking: Advanced problem-solving skills, with the ability to identify root causes, develop actionable insights, and implement sustainable improvements + Adaptability: Comfortable managing change in a dynamic healthcare environment and fostering a culture of continuous improvement + Results-Oriented: Proven track record of delivering measurable improvements in operational efficiency, patient outcomes, and resource utilization **JOIN OUR TEAM TODAY!** Emory Healthcare (EHC), part of Emory University (EUV), is the most comprehensive academic health system in Georgia and the first and only in Georgia with a Magnet designated ambulatory practice. We are made up of 11 hospitals-4 Magnet designated, the Emory Clinic, and more than 425 provider locations. The Emory Healthcare Network, established in 2011, is the largest clinically integrated network in Georgia, with more than 3,450 physicians concentrating in 70 different subspecialties. **Additional Details** Emory is an equal opportunity employer, and qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by state or federal law. Emory Healthcare is committed to providing reasonable accommodations to qualified individuals with disabilities upon request. Please contact Emory Healthcare's Human Resources at *************************** . Please note that one week's advance notice is preferred. **Connect With Us!** Connect with us for general consideration! **Division** _Emory Decatur Hospital_ **Campus Location** _Decatur, GA, 30033_ **Campus Location** _US-GA-Decatur_ **Department** _DEC Operational Excellence_ **Job Type** _Regular Full-Time_ **Job Number** _144619_ **Job Category** _Business Operations_ **Schedule** _8a-5p_ **Standard Hours** _40 Hours_ **Hourly Minimum** _USD $44.38/Hr._ **Hourly Midpoint** _USD $54.07/Hr._ Emory Healthcare is an Equal Employment Opportunity employer committed to providing equal opportunity in all of its employment practices and decisions. Emory Healthcare prohibits discrimination, harassment, and retaliation in employment based on race, color, religion, national origin, sex, sexual orientation, gender identity or expression, pregnancy, age (40 and over), disability, citizenship, genetic information, service in the uniformed services, veteran status or any other classification protected by applicable federal, state, or local law.
    $44.4-54.1 hourly 60d+ ago
  • Senior IAM Engineer (Hiring Immediately)

    McKesson 4.6company rating

    Alpharetta, GA jobs

    McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve we care. What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrows health today, we want to hear from you. The Senior IAM Engineer will provide subject matter expertise and support the analysis, design, and implementation for hybrid on-prem and cloud Active Directory environments and Azure Active Directory/Entra ID tenants. This role includes engaging and collaborating with business and technical partners to integrate systems and applications with centralized authentication such as Active Directory or Azure Active Directory/Entra ID. Responsibilities: Provide deep subject matter expertise and support the analysis, design, and implementation for hybrid on-prem and cloud Active Directory environments and Azure Active Directory/Entra ID tenants. Engage and collaborate with business and technical partners to integrate systems and applications with centralized authentication such as Active Directory or Azure Active Directory/Entra ID. Provide deep subject matter knowledge and expertise on Active Directory, Azure Active Directory/Entra ID, and Okta Active Directory synchronization. Support new product comparison, vetting, and selection process to ensure technology is relevant and meets business requirements. Drive Active Directory and Entra ID disaster recovery drills, process improvements, and documentation efforts. Continually enhance authentication platforms, ensuring systems are protected from new and evolving Cyber threats and systems are operationally stable. Collaborate closely with global cross-functional teams to ensure the stability, scalability, and security of the Active Directory and Azure Active Directory/Entra ID environments and Okta. Participate in discussions on all aspects of identity and access management. Respond to and resolve complex, high-severity incidents. Lead regular reviews of deployed infrastructure, develop detailed architecture, and create and update new technical documentation and Standard Operating Procedures (SOP). Analyze the current authentication services platforms to identify both technical and operational opportunities for enhancements and develop continuous improvement action plans. Lead regular assessment of systems and process hygiene and identify and implement automation. Actively research and implement new innovations in IT security as well as IAM technologies and services, striving to ensure McKesson continues to deliver best practices and standards. Provide on-call support as needed for operational continuity of Identity platforms. (1 week rotation for ON-call) Minimum Requirements: Degree or equivalent and typically requires 7+ years of relevant experience. Critical Experience/Skills: Proven experience as an Active Directory/Entra ID Engineer or similar role with a minimum of 7 years of experience. Proven ability to effectively prioritize and execute tasks with competing priorities; strong influencing skills to work with various service owners. Demonstrated experience effectively leading and managing collaborative, service management solutions across disparate functional teams. Preferred Experience/Skills: Advanced understanding of Active Directory, Azure Active Directory/Entra ID, Lightweight Directory Access Protocol, Active Directory Federation Services, and other centralized identity stores. Advanced understanding of Microsoft Azure and familiarity with IAM permissions on Management Groups, subscriptions, and resources. Advanced knowledge of Azure Active Directory/Entra ID capabilities such as Conditional Access Policies, Privileged Identity Manager, and Application Registrations. Advanced understanding of Active Directory attributes, LDAP Queries, PowerShell Scripting, Active Directory Federation Services (ADFS), Group Policy Object (GPO) analysis, configuration, and item-level targeting, active directory replication, Active Directory backup and restore, as well as certificate installation. Advanced understanding of implementing security on Active Directory and Entra ID and hardening those platforms. Advanced understanding of Active Directory and Entra ID backup and restore processes and experience of performing Disaster Recovery exercises. Advanced understanding of Windows Server operating systems and Active Directory/Azure Active Directory/Entra ID services. Advanced understanding of PowerShell scripting with proven experience implementing automation, including experience utilizing APIs such as Microsoft Graph. Advanced understanding of Single-Sign On and authentication protocols such as SAML & OIDC. Excellent problem-solving skills and ability to work well under pressure. We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. For more information regarding benefits at McKesson, pleaseclick here. Our Base Pay Range for this position $121,300 - $202,100 McKesson is an Equal Opportunity Employer McKesson provides equal employment opportunities to applicants and employees and is committed to a diverse and inclusive environment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age or genetic information. For additional information on McKessons full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page. Join us at McKesson!
    $121.3k-202.1k yearly 4d ago
  • MTA Senior IAM Engineer (Hiring Immediately)

    McKesson 4.6company rating

    Alpharetta, GA jobs

    McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve we care. What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrows health today, we want to hear from you. As a Senior Identity and Access Management (IAM) Engineer, you will be a part of McKesson's Identity and Access Management team. You will contribute during phases of design, configuration, deployments, and operations in areas of Single Sign-On (SSO), multi-factor authentication (MFA) and IAM orchestrations. This position will need hands-on engineering experience in a fast-paced environment, working with Business and Internal customers to deliver complex authentication solutions. Expectations include strong debugging and issue triaging skills to mitigate risks, resolve issues and deliver modern authentication solutions. This position will also support the engineering, building, and scaling of our authentication infrastructure to deliver authentication solutions, establish and improve IDP resiliency across platforms. Essential Responsibilities and Functions: Deliver modern authentication solutions for B2B, B2C and B2E customers leveraging tools such as Okta, Microsoft Entra ID. Collaborate with business and technical partners to integrate systems and provide IDP resiliency. Strong experience in Okta versions such as Okta Classic and Okta Identity Engine (OIE) or equivalent technologies. Good experience in the development of authentication workflows. Strong experience in configuring and enabling Single-Sign On (SSO) and Multi-factor authentication (MFA) for internal or external facing application systems. Lead the collaboration and discussion with business, application, and system stakeholders on meeting authentication policies and standards. Lead design and code review and perform quality inspections to ensure the consistent application of good engineering practices in adherence with McKesson standards, processes, and best practices. Perform Proofs of Concepts (PoCs) to assess and identify the technologies per the needs of the organization. Qualifications: Minimum Requirements: Degree or equivalent and typically requires 7+ years of relevant experience. Critical Experience/Skills: Industry experience in the field of Identity and Access Management. Hands-on experience developing/configuring authentication solutions using Okta or other industry authentication solutions (E.G; Auth0, Azure/Entra ID, PingFederate etc.). Hands-on experience establishing and improving IAM resiliency solutions. Integration experience with SSO leveraging industry protocols such as SAML, OpenID Connect, OAuth and WS-FED. Experience integrating and federating different IDM technologies across multiple domains. Understanding of enterprise identity infrastructure and core security concerns of cloud and on-premises environments. Strong analytical and problem-solving skills, pride in ownership and ability to troubleshoot complex IAM issues. Excellent communication and interpersonal skills, with the ability to collaborate effectively with both technical and non-technical stakeholders. Preferred Experience/Skills: Programming languages (PowerShell, Python, Terraform, Java, JavaScript, .NET etc.). Integrating and federating different IDM technologies. Certifications such as CISSP, CISM, Okta, or Azure are a plus. 4-year degree in IT or related field or equivalent experience. We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. For more information regarding benefits at McKesson, pleaseclick here. Our Base Pay Range for this position $121,300 - $202,100 McKesson is an Equal Opportunity Employer McKesson provides equal employment opportunities to applicants and employees and is committed to a diverse and inclusive environment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age or genetic information. For additional information on McKessons full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page. Join us at McKesson!
    $121.3k-202.1k yearly 4d ago
  • Process Validation Engineer, Expert

    Agilent Technologies, Inc. 4.8company rating

    Boulder, CO jobs

    Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Information about Agilent is available at **************** The world's most revolutionary biopharma companies are partnering with Agilent Technologies to advance the next frontier of medicine. Agilent continues to invest in capacity and expansion of its Colorado operations. Join our team of professionals dedicated to the development and commercialization of nucleic acid therapeutics for life changing, lifesaving medicines. Agilent Technologies Nucleic Acids Solutions Division is looking to for a Process Validation Engineer to join their Process Validation team working at their state-of-the-art, contract Active Pharmaceutical Ingredient manufacturing facility that specializes in oligonucleotide chemistries located in Boulder and Frederick, Colorado. Job Description As a Process Validation Engineer within the Process Validation team of Agilent Technologies Nucleic Acid Solution Division, the candidate will be responsible for executing process validation activities of oligonucleotide Active Pharmaceutical Ingredient (API) manufacturing. The responsibilities may include: * Compile, generate and review process inputs and outputs using statistical process control measures for product quality and process consistency reports. * Perform process characterization / validation studies at the bench and in a plant setting, including contributing to the design and writing of the study and associated study documents. * Facilitate multiple aspects of an API process qualification strategy through designing/ authoring/executing/reporting/ investigating of process qualification studies. * Contribute knowledge and ideas for the development of manufacturing control strategies, methods and techniques in synthesizing, purifying, identification and control of impurities. * Support the design and execution of Design of Experiments (DOE) and Proven Acceptable Range (PAR) experiments for design space understanding and process validation as they relate to oligonucleotide upstream and downstream operations. * Supports all areas of process validation from FDAs Product Lifecycle Stages 1, 2 and 3. * Provide work product updates to clients and project teams in the form of slides, memos and reports. * Maintains process compliance integrity by adhering to standard operating procedures and current good manufacturing practices. * Contribute knowledge and ideas for process optimization, scale-up and laboratory process transfer to mid and kilo scale GMP manufacturing. Qualifications * Bachelor's degree (B. S.) or equivalent in chemistry, chemical engineering or related applied sciences field * Knowledge and 8+ experience in a GMP API setting. * Knowledge and understanding unit operations and associated control strategy of an oligonucleotide manufacturing process or like process. * Knowledge and experience in process validation studies at the bench and in a plant setting. * Knowledge and experience in the development of manufacturing control strategies, methods and techniques in synthesizing, purifying, identification and control of impurities. * Knowledge and experience in designing, conducting, and statistical interpretation in Design of Experimentation (DOE), preferably using SAS JMP software is highly desirable #LI-TH1 Additional Details This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least November 17, 2025 or until the job is no longer posted. The full-time equivalent pay range for this position is $105,280.00 - $164,500.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: ************************************* Agilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_******************* or contact ***************. For more information about equal employment opportunity protections, please visit ********************************* Travel Required: No Shift: Day Duration: No End Date Job Function: R&D
    $105.3k-164.5k yearly Auto-Apply 49d ago
  • Manufacturing/Validation Engineer

    Agilent Technologies 4.8company rating

    Carpinteria, CA jobs

    Job DescriptionLead the qualification of production equipment and the validation of manufacturing processes in a regulated medical-device environment. Create URS and FMEA documentation, execute risk-based IQ/OQ/PQ/SQ, support CAPA/NCRs, manage cross-functional projects, drive CI/Six Sigma improvements, write SOPs, and train production staff-ensuring compliance with 21 CFR Part 820, 21 CFR Part 11, and ISO 13485. Role Description Equipment Qualification & Process Validation: Develop URS, conduct risk assessments, plan/execute IQ/OQ/PQ/SQ, manage deviations, and produce audit-ready reports. CAPA/NCR Support: Lead/participate in root-cause investigations, define corrective/preventive actions, verify effectiveness, and maintain clear documentation Project Management: Build schedules and budgets, coordinate vendors, track risks/issues, and report status to stakeholders through stage-gate milestones. CI / Six Sigma: Apply DMAIC, PFMEA, SPC/CPK, MSA/Gage R&R, and DOE to reduce waste, improve yield/throughput, and sustain process capability. SOP & Document Control: Author and revise SOPs, work instructions, forms, and validation documentation under change control; maintain inspection-ready files. Training & Enablement: Develop training materials; coach technicians and operators on new equipment, validated processes, and documentation standards. Compliance & Readiness: Support internal/external audits; ensure Part 11 data integrity (ALCOA+) for computerized/automated systems. Qualifications B.S. in Mechanical, Electrical, Chemical, Biomedical, Industrial or related engineering field. 4+ years in medical device (or similarly regulated) manufacturing. Hands-on ownership of URS, FMEA, and IQ/OQ/PQ/SQ deliverables for equipment and processes. Experience supporting CAPA/NCR lifecycle Working knowledge of 21 CFR 820, 21 CFR Part 11, ISO 13485 Strong technical writing and cross-functional communication; solid project coordination skills. Nice to Have Exposure to automation/MES/SCADA/PLC, data acquisition, or vision/inspection systems. Proficiency with Lean/Six Sigma methods (5S, VSM, SPC, DOE, MSA); Six Sigma Green Belt preferred. Tools: Agile PLM, MS Project/Smartsheet; basic SQL/Power BI a plus. Certifications: PMP, Additional Details This job has a full time weekly schedule. Applications for this job will be accepted until at least October 1, 2025 or until the job is no longer posted.The full-time equivalent pay range for this position is $104,774.00 - $163,710.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: ************************************* Agilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_******************* or contact ***************. For more information about equal employment opportunity protections, please visit *************************************** Required: OccasionalShift: DayDuration: No End DateJob Function: Manufacturing
    $104.8k-163.7k yearly Auto-Apply 60d+ ago
  • Cleaning Validation Engineer (Remote)

    Mindful Quality 4.2company rating

    Florida jobs

    Mindful Quality is a growing consulting firm in the Biotechnology and Pharmaceutical industries. Mindful Quality specializes in cleaning validation, process development, project management, and regulatory guidance related to manufacturing quality assurance. The Cleaning Validation Engineer is responsible for cleaning process engineering and validation for our clients. The position will involve supporting cleaning cycle development, cleaning validation, and continuous cleaning monitoring in cGMP facilities. Ideal candidate has experience in cleaning validation including CIP, COP, and manual cleaning. The Role Assess client's cleaning validation documents to identify regulatory concerns including potential corrective actions in alignment with industry best practices. Troubleshoot cleaning failures, develop, and optimize cleaning processes. Write, revise, and review cleaning related documents including Master Plans, Project Plans, Batch Records, Standard Operating Procedures, Forms, Protocol, Summary Reports, Forms, Risk Assessments, etc. Interact with team members and clients to create, review, and approve documentation per timeline. Plan and track project deliverables. This includes coordination with internal and external team members. Create, develop, edit, and maintain high-quality documentation following internal and client style guidelines, document standards, and templates, while ensuring that quality targets, timelines, and regulatory requirements are met. Create, manage, and help close out protocol exceptions and deviations Manage protocol execution paperwork as needed to support clients. Create and manage Change Control and CAPA documentation Look for ways to continuously improve generated documentation Communicate effectively with team members and external vendors/clients Develop training materials for manufacturing staff based on SOPs authored. Mentor and train client staff on cleaning validation principles Other duties as assigned by manager The Candidate Degree in Chemistry, Biochemistry, Pharmacy, Engineering, or other related fields 5+ years' experience in cleaning validation within a regulated manufacturing environment. Preferrable Pharmaceutical or Biotechnology industry. Working knowledge of GMPs - Preferred Hands-on experience with the following systems: CIP systems, parts washers, manual cleaning is required. Experience with rinse and swab sampling techniques Proven ability to review, interpret and make scientific conclusions and recommendations based on data Ability to understand and extract necessary information from technical documents 2-5 years of technical writing experience Excellent grammar and writing skills - Required Effectively work within a team environment and interface with peers, management, etc. Ability to work independently, handle multiple tasks simultaneously and to meet critical milestones and goals. - Required Able to effectively manage workload and prioritize activities Proficient computer skills Advanced knowledge of Microsoft Word/Excel/PowerPoint - Required Must be willing to travel to client sites worldwide to support work as needed.
    $67k-91k yearly est. 60d+ ago
  • Manufacturing Engineer

    Green Thumb Industries 4.4company rating

    Remote

    The Role The Manufacturing Engineer is responsible for developing automated solutions, implementing new processes, optimizing existing processes, automated data collection, and executing the industrial control and programming strategy for GTI's production facilities. This position will work closely with the multiple teams to ensure flawless and quick speed to market. Success is gauged on the ability to deliver quality, detailed, and efficient solutions at scale. The Manufacturing Engineer will play a pivotal strategic role in priority projects from a feasibility standpoint through a full IQ, OQ, PQ validation and hand-off with a technical transfer to the site production team. They work collaboratively with multiple teams to deliver productivity improvements and Continuous Improvement. Responsibilities 50% travel required Coordinate the efforts of Engineering and technical resources based on Senior Leadership Priorities and Site 90-day plan priorities. Work with other departments (i.e. Prod Development, Project Management, Quality, Compliance, Operations, etc.) to integrate new systems. Dedicate start-up management support for selected complex project integrations. Ensures constant updates are provided to the VP of Manufacturing on the status of projects and improvement efforts in the facilities. SME for automated packaging equipment, flow wrappers, beverage line, multi-combi scales, bag filling equipment, integrations, and automation. Conduct studies, identify problems, recommend alternatives, and implement solutions in coordination with other teams. Develop and deploy automated solutions for numerous processes to gain efficiency and streamline workflows. Provide support to Start-up facilities via technical transfer: Staffing Equipment layout and requirements Construction hand off Regulatory engagement Best-practice processes Technical transfer related to equipment Work with integrators, contractors, and site personnel to bring new functionality online and to troubleshoot issues as they arise. Work with site maintenance and facilities personnel to develop and execute preventative maintenance plans. Maintain up to date as-built records and drawings for existing and new deployments. Integrate existing equipment with live data stream to dashboard with historian, report generation, alarms, notifications, and live visuals for site teams to track daily production. Other duties as assigned Qualifications Bachelor's degree in engineering and 5+ years Operations and Engineering experience in a manufacturing environment. Proven strategic experience in overseeing all aspects of large-scale manufacturing projects Knowledgeable of TPM-based continuous improvement methodology Knowledgeable of Engineering problem solving Able to diagnose complex technical systems and develop simple human-machine interface and training solutions for optimal operations. Experience in industrial networking/automation (SCADA-Ignition, ITOT, cyber security), controls experience (PLC - AB, Omron, Schneider, ladder logic \ STX), business and data analytics for manufacturing operations (Power Bi, Tableau,) vision systems, and robotics. Highly motivated, self-directed, innovative and able to work independently or among teams with keen judgement, common sense and resourcefulness Adapts and thrives in a demanding, start-up, fast-paced environment Possesses a high level of critical thinking Effective time-management skills and ability to multi-task Ability to work well with others while also completing individually assigned tasks. Operates with a high level of professionalism and integrity, including dealing with confidential information Must understand and comply with the rules, regulations, policies, and procedures of GTI Must have a solid understanding of the Medical Marijuana laws, rules and regulations set forth by the state; a pursuit to further their understanding and knowledge of the industry and the laws. Safety and Compliance Be aware of hazards in the workspace. Retain and understand department specific training. Report safety incidents/ concerns and comply with follow-up actions. Be compliant with area safety requirements, state regulations and PPE requirements. Follow GMP, biosecurity, sanitation or other quality and compliance requirements. Perform record keeping accurately and completely as directed by a lead or supervisor. Maintain and calibrate tools, equipment and machinery as directed by a lead or supervisor. Report and escalate safety & quality concerns. Working Conditions While performing the duties of this job, the employee is regularly required to perform reaching, grasping, bending, stooping, talking, hearing, seeing and repetitive motions. Must be able to sit and/or stand for extended periods of time while maintaining focus. Must be able to lift, carry, and balance up to 50 pounds (and up to 100 pounds with assistance) AND must be able to do so with extreme care and caution when working with product. Ability to work in a fast-paced, changing, and challenging environment Work involves daily exposure to allergens (such as cannabis, tree nuts, and coconut oil). Additional Requirements Must pass any and all required background checks Must be and remain compliant with all legal or company regulations for working in the industry Must possess valid driver's license Must be a minimum of 21 years of age Must be approved by state badging agency to work in cannabis industry The pay range is competitive and based on experience, qualifications, and/or location of the role. Positions may be eligible for a discretionary annual incentive program driven by organization and individual performance. Green Thumb Pay Range$90,000-$110,000 USD
    $90k-110k yearly Auto-Apply 60d+ ago
  • Lead Product Security Engineer (R&D Cytology)

    Hologic 4.4company rating

    San Diego, CA jobs

    Marlborough, MA, United States San Diego, CA, United States Discover a career with real meaning. One that offers the opportunity to showcase your talents, achieve measurable success and gain immense satisfaction by enabling healthier lives everywhere, every day. Our Software Engineering (R&D) department in our Diagnostics division is looking for a Security Engineer experienced in medical device and/or instruments security and systems to join our team, pivotal in building and enhancing security in our products and services! As a **Lead Product Security Engineer** and the SME for our Cytology R&D team, you will the key cybersecurity representative ensuring that our products are meeting industry standards and FDA requirements throughout the product lifecycle, including post-market. This is a hybrid role based out of either Marlborough, MA or San Diego, CA. **Key responsibilities and applied experience required from a candidate:** + Maintain vigilance on industry security threats, assess risks to Hologic products, and manage these risks according to established quality procedures. + Participate in continuous improvement of our Secure by Design principles and implementation, ensuring adherence to security standards and best practices. + Support the creation and maintenance of security design documentation and architecture diagrams. + Collaborate with cross-functional teams (Product Engineering, DevSecOps, Regulatory, Quality) to integrate security into the product lifecycle. + Define security requirements and controls based on specific use cases and threat models. + Perform regular risk analyses to evaluate security threats and vulnerabilities, prioritizing uncontrolled risks with potential impacts on patient safety. + Perform Security Risk Management activities to address identified vulnerabilities and security design issues, including regular review and assessment of risk against CVEs. + Establish automated processes for vulnerability scanning and remediation + Educate the development and leadership teams on securing products, remote connectivity solutions, and their operating environments. + Work with cross-functional teams to ensure that SBOMs are correct and can be used as part of our continuous vulnerability monitoring process + Design architecture that prioritizes efficient, secure software updates and patch management across deployed systems. + Establish incident playbooks and coordinate root cause analysis (RCA) for reported security incidents. + Work with DevSecOps and Software Engineers to review code static analysis and third-party software assessment reports. **Experiences that are nice to have:** + Collaborate with Program Management and Regulatory teams to provide security input for audits and FDA submissions. + Maintain current knowledge of FDA and other regulatory body's cybersecurity guidance and standards, such as ISO, IEC, NIST, AAMI, CSLI, UL, BSI, HIPAA, + GDPR, State and Federal security standards, and ACTS for premarket and post-market activities. + Assist in translating cybersecurity requirements into product requirements for new and existing product designs, as well as assisting with the definition of verifications for traceability. + Assist with efforts to establish penetration testing suites for continuous testing and monitoring of our product solution. **Minimum Requirements:** + Bachelor's or Master's degree in Computer Science, Cybersecurity, or related engineering equivalent. + Minimum of 8 - 12 years of professional experience in product security/cybersecurity engineering + Demonstrated competency in Cybersecurity education and training through certifications (e.g., CISSP, CompTIA Security+, etc.) + Strong interpersonal skills, with the ability to communicate cybersecurity concepts to a variety of audiences. + Skilled in working within cross-functional groups. + Skilled in performing Risk Assessment and Management plan + Skilled in writing design documentation and standard operating procedures. + Experience working in an FDA regulated environment is required. + Thorough familiarity with FDA and other regulatory body Cybersecurity Guidelines and cybersecurity standards such as NIST, AAMI, CSLI, UL, BSI, HIPAA, GDPR, State and Federal security standards, and ACTS for premarket and post-market activities. + Strong verbal & written communication skills. + Familiarity with Windows OS and cloud-based solutions is required + Expertise with security frameworks and testing tools, and how to incorporate the results of those into cybersecurity requirements for the Product Development team. + Proficiency in scripting and simple test automation (e.g., PowerShell, Python). The annualized base salary range for this role is $131,500 to $205,800 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand. **Why Hologic?** We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. If you have the right skills and experience, **apply today!** \#LI-RF1 #lead-level Agency and Third Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
    $131.5k-205.8k yearly 60d+ ago
  • Principal R&D Engineer - Endoscopes

    Noah Homes 4.1company rating

    San Carlos, CA jobs

    Who We Are Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications. We are looking for exceptional engineers and key team members. Our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics, and Hansen. We are looking for talented, motivated and ambitious team members to revolutionize robotic surgery. About The Team Noah Medical's Instruments & Accessories (I&A) team develops advanced endoluminal instruments and flexible endoscopes that enable safe, effective, and transformative robotic procedures. We are a dynamic, data-driven team that thrives on collaboration, creativity, and first-principles thinking. Our mission is to deliver products that physicians trust and patients benefit from - on time and with uncompromising quality. We are seeking a Principal R&D Engineer, Endoscopes who will serve as a technical thought leader and mentor within the I&A organization. This individual will guide engineers through all stages of product development - from concept and architecture definition through verification, transfer to manufacturing, and post-market refinement. This role demands a hands-on engineer with deep experience in flexible endoscopes (e.g., bronchoscope, ureteroscope, gastroscope, or similar systems) and a mastery of mechanical first principles. The ideal candidate is equally comfortable modeling in CAD, building and testing prototypes, and collaborating across clinical, and robotics/controls teams to define and optimize system-level performance. A Day In The Life Of Our Principal R&D Engineer - Endoscopes Lead the architecture, design, and development of next-generation flexible robotic endoscopes and endoluminal instruments. Act as a technical mentor and coach, guiding engineers through design control, risk management, verification, and design-for-manufacture practices. Apply mechanical first principles to characterize, model, and tune key performance parameters (e.g., torque response, bending stiffness, tip control, articulation fidelity). Collaborate closely with Clinical Engineering to define and execute high-fidelity simulated use testing, ensuring that bench results translate to clinical value. Partner with Robotics and Controls Engineering to develop deterministic control strategies by quantifying and improving the mechanical behavior of flexible devices. Independently design, prototype, and test concepts using rapid iteration and data-driven decision-making. Lead design reviews and provide critical feedback across the I&A portfolio to ensure consistency, robustness, and alignment with system-level goals. Develop and document requirements, specifications, and verification methods for subsystems and components. Drive continuous improvement in performance, reliability, manufacturability, and cost. About You B.S. or M.S. in Mechanical Engineering, Biomedical Engineering, or related field with 12+ years of experience in product development; experience in medical devices or other regulated industries preferred. Proven expertise in flexible endoscope design and development, including working knowledge of distal articulation, steering mechanisms, and insertion tube construction. Strong grasp of mechanical fundamentals (kinematics, friction, compliance, tolerance stack-up, materials, and fatigue). Demonstrated ability to identify and manipulate mechanical parameters that affect clinical performance. Hands-on proficiency with CAD (SolidWorks or equivalent), prototyping, and test method development. Experience with design-for-manufacture techniques, including machining, injection molding, laser cutting, and extrusion. Demonstrated success in cross-functional collaboration, particularly with clinical, robotics, controls, and manufacturing engineers. Ability to balance conceptual innovation with practical execution under schedule and resource constraints. Exceptional communication skills and the ability to influence technical direction across teams. Passionate about building products that advance minimally invasive care and improve patient outcomes. #LI-Onsite Pay Transparency The Pay Range for this position is listed. Noah Medical offers a comprehensive benefits package including: competitive pay, health insurance, 401K and stock purchase plans, tuition reimbursement, paid time off plus holidays, and a flexible approach to work with remote, hybrid, field or office work schedules. Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors such as location as permitted by law. Total compensation may also include additional forms of incentives. California Pay Range$190,000-$238,000 USD Benefits & Perks (For Full Time Employees): Competitive Salary Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options Equity & Bonus Program Life Insurance (company paid & supplemental) and Disability insurance Mental health support through medical insurance programs Legal and Pet Insurance 12+ paid holidays, 15-20 days of PTO + sick time Paid parental leave In-office snacks and beverages In-office lunch stipend Learning & Development Opportunities: On-demand online training and book reimbursement Team building and company organized social and celebration events Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable. Noah Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to ensuring an inclusive environment for our employees. Applicants are considered for all positions without regard to race, color, religion, sex or gender, gender identity or expression, sexual orientation, national origin, ancestry, age, genetic information, physical or mental disability, marital or protected military or veteran status, or any other consideration made unlawful by federal, state or local laws. Please visit our Careers Page to view our latest openings. NO AGENCIES PLEASE - Please do not outreach to any managers or submit any resumes without a signed agreement from Talent Acquisition. Resumes shared with anyone at Noah Medical without a signed agreement will be considered your gift to us and no fee will be paid.
    $190k-238k yearly Auto-Apply 52d ago
  • Validation Engineer

    PSC Biotech 3.9company rating

    Irvine, CA jobs

    PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. The Experience With operations spanning the globe and featuring a multi -cultural team, PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech , it's about more than just a job-it's about your career and your future. Your Role Our Validation Engineers support the full CQV lifecycle, ensuring facilities, utilities, equipment, computerized systems, and manufacturing processes are designed, installed, operated, and maintained in compliance with FDA, EU, and global GxP regulations. This role plays a critical part in reducing compliance risks and enhancing operational performance while executing high -quality validation deliverables, providing technical expertise, and supporting regulatory readiness. Responsible for the planning, commissioning, qualification, and validation activities for required cGMP manufacturing and lab equipment, utilities, and computerized systems. Author, review, and execute validation deliverables including but not limited to validation plans, design specifications, user requirement specifications, risk assessments, DQ, IQ, OQ, PQ generation and testing, summary and final reporting. Perform system readiness assessments and verification testing. Ensure systems meet user requirements, functional specifications, and data integrity expectations. Manage system implementation activities including configuration, backup/restore, and periodic reviews. Write, review, and approve SOPs; ensure documentation is accurate, traceable, audit -ready, and compliant. Participate in deviation investigations, root cause analysis, and support CAPA implementation and change control processes. Provide user training and ongoing technical support. Collaborate with cross -functional teams to align on technical functions, deliverables, and quality events. Additional responsibilities as required to drive project success. Requirements Bachelor's degree in engineering or related technical discipline. 3-10 years of experience in validation within GMP -regulated environments (pharmaceutical or biotech). Hands -on experience validating GxP manufacturing and lab based equipment, analytical instruments, and associated computerized systems. Strong understanding of full lifecycle validation and risk -based approach. Well -versed in regulatory requirements and guidelines (FDA, EMA, ICH, cGMP, GAMP 5, 21 CFR Part 11, EU Annex 11). Experienced with traceability, change control, deviation handling, and CAPA management. Strong technical writing and documentation skills. Excellent attention to detail, problem -solving, and analytical skills. Ability to manage multiple projects and timelines. Willingness to travel as needed for project assignments and client engagements. Must be authorized to work in the US. No C2C at this time. BenefitsOffering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy. Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more. 401(k) and 401(k) matching PTO, Sick Time, and Paid Holidays Education Assistance Pet Insurance Discounted rate at Anytime Fitness Financial Perks and Discounts Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $75,000 - $125,000 annually. The salary offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience. Equal Opportunity Employment Statement PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer -sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law. #LI -RD1
    $75k-125k yearly 12d ago
  • R&D Engineer I

    Penumbra 4.4company rating

    Alameda, CA jobs

    General Summary The Research and Development Engineer I engineers, designs, and develops new products or changes to existing products, processes, and equipment. Performs testing, implementation, and documentation of engineering changes. Uses both theoretical and practical solution development through the application of scientific and design of experiment processes. Specific Duties and Responsibilities • Assist in design, development, and testing of Penumbra, Inc. products* • Create engineering test protocols* • Run and report engineering tests* • Design fixtures and tooling to facilitate prototype assembly and material testing • Evaluate prototypes against standards or specifications and troubleshoot problems to assess root cause and corrective action • Interpret and communicate test results* • Solve practical problems encountered* • Document findings and recommendations* • Present findings to project managers* • Adhere to the Company's Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. * • Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. * • Ensure other members of the department follow the QMS, regulations, standards, and procedures. * • Perform other work-related duties as assigned. *Indicates an essential function of the role Location and Salary Alameda, CA$80,000 to $105,000 Position Qualifications Minimum education and experience: • Bachelor's degree in Engineering, Physical Sciences or related technical field or equivalent combination of education and experience. Additional qualifications: • Medical device industry experience desired • Verbal, analytical, computer and hands-on laboratory skills required Working Conditions • General office, production, laboratories, and controlled environment facility. • Potential exposure to blood-borne pathogens. • Requires some lifting and moving of up to 25 pounds. • Must be able to move between buildings and floors. • Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day. • Must be able to read, prepare emails, and produce documents and spreadsheets. • Must be able to move within the office and access file cabinets or supplies, as needed. • Must be able to communicate and exchange accurate information with employees at all levels on a daily basis. What We Offer•A collaborative teamwork environment where learning is constant, and performance is rewarded. •The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases. •A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s). Penumbra, Inc. , headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws. If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents. For additional information on Penumbra's commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.
    $115k-162k yearly est. Auto-Apply 51d ago
  • Computer Vision R&D Engineer

    DHD Consulting 4.3company rating

    San Diego, CA jobs

    We are seeking an Intermediate Computer Vision R&D Engineer to join our team. The candidate will be part of the core team of computer vision engineers. We will be developing new product lines, including quality inspection systems in many different industries, medical equipment, as well as other exciting applications which use 3D imaging technologies and Machine Learning. As a computer vision engineer, you will be using cutting-edge vision and AI algorithms to integrate into robotics systems designed by worldwide teams of software, mechatronics, electronics, physics and optics engineers. (interdisciplinary and collaboration) Responsibility - Research and develop scalable and cutting-edge computer vision for 3D reconstruction, 2D/3D imaging technologies, camera calibration, object detection, image processing, denoising, segmentation and metrology. - Research, develop and employ machine learning algorithms for solving difficult and exciting challenges. - Engineer solutions for quality inspection equipment, medical equipment, and more. - Design, implement, and deploy full-stack machine vision/image-based and machine learning solutions, using C++ and Python. - Participate in weekly Group Genius activities, where all members take the lead and create ideas, with the mindset that innovation can happen by anyone and anywhere. - Performs other duties as assigned Skills and Qualifications - Masters degree required - Ph.D preferred - Experience to Research and Develop to Classical Computer Vision Algorithm - Experience to Research and Develop Machine Learning - Experience to Deploy CUDA processing - C++ code optimization in performance-wise to image processing - Experience with at least of the programming language C++ / Python / CUDA Have at least one of the followings: - Computer Vision algorithms and applications, such as 3D reconstruction(structured light, multi-view geometry, etc), object detection, recognition, image processing, and their optimizations for efficient implementation. - Machine Learning, such as CNN/deep learning, shallow learning and their optimizations for efficient implementation on embedded systems - Algorithm optimization for efficient processing, exploiting parallelism, and GPU - Experienced in use of Machine learning and computer vision frameworks and libraries such as Tensorflow, Pytorch, Caffe, Torch, OpenCV, etc (>2years) - C++ programming skills, preferably in an embedded environment with GPU and familiar with UML Benefits - Health/Dental/Vision/Life Insurance at NO employee premium (including dependent coverage) - 401(k) retirement plan (Immediately 100% vested) - Generous PTO and paid holidays
    $107k-145k yearly est. 60d+ ago
  • Engineering Project Feasibility and Product Sourcing Leader

    Genentech 4.5company rating

    Oceanside, CA jobs

    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 7d ago
  • Pre and Post Silicon Validation Engineer

    Insilico 3.6company rating

    San Diego, CA jobs

    Insilico is an End-to-End specialized VLSI, Embedded Design & Software services and solutions company. It operates in the “Compute” & “Connectivity” space. Insilico is founded by industry veterans, who are strong leaders and practitioners with diverse experience in all the relevant aspects of technology and execution. The management and its entire team, handpicked from among the best talents in the industry, can adapt to the evolving technologies and growing market challenges internationally. Insilico has very flexible business models to suit a plethora of client needs. With a current clientele of top semiconductor companies, Insilico has a wide and diversified spectrum of service offerings in expansive domains within the ambit of Embedded Design & Software, and in almost all areas of VLSI design, from Spec-to-Silicon, on a wide range of ASICs & CPUs/GPUs in all the latest technologies, including 7nm. Being an integral part of a larger business eco-system, Insilico has the foundation of strong financials, validated processes, robust infrastructure and a global network of reputable clientele. Insilico's service portfolio caters to products that empower the world of Communication, Networking, CPU/Servers, Automobile, Bio-Medicals, Consumer Electronics and a wide range of IOTs. Headquartered in the US, it has operations in India & APAC. Job Description Job Role: Pre and Post Silicon Validation Engineer Location: San Diego, CA Duration: 24 Months Pre and Post Silicon Validation Team is part of the central SoC digital hardware organization responsible for the overall quality of the SoC silicon. The Validation team works closely with architects, designers, verification engineers, software engineers, and customers. The team is currently seeking candidates who are familiar with pre-silicon test development and post-silicon bring-up and validation. Qualifications Candidate will have a minimum of 3 years of SW/FW experience working in emulation and silicon environments. Candidates are expected to have experience in: - Low Level software development in C and Assembly. - Debugging low level software and hardware issues. - Implementing drivers and test content. - Debug tools including JTAG, Logic Analyzer, Oscilloscope, etc., and kernel debuggers. - Emulation environments for development and debug. - Basic understanding of power and performance. - Knowledge of SOC architecture and in-depth knowledge of at least one sub system (CPU, Power Management, Security IPs, System Performance, Clocks, DDR, etc.) - Good communication skills and ability & desire to work in a cross-functional team environment. Additional Information Experience with post-silicon enabling and bring-up. Understanding of coherency and concurrency in modern SoC architectures. Experience with at least one of: Perl, Python, TCL, C++, or Java. Industry experience preferred but not required. All your information will be kept confidential according to EEO guidelines.
    $89k-116k yearly est. 8h ago
  • R&D Engineer II - Embedded Firmware

    Penumbra Inc. 4.4company rating

    Alameda, CA jobs

    As an R&D Engineer at Penumbra, you get to be hands-on, prototyping the next generation of medical devices! We are looking for someone who is excited about rolling up their sleeves to relentlessly iterate new ideas for electro-mechanical systems. You will work collaboratively to apply your passion for creative problem solving at all stages of the design process, from concept to commercialization, which will have a profound positive impact on patients worldwide. What You'll Work On * Play a key role in early-stage development of the next generation of Penumbra products * Be a pivotal team member for prototyping and designing electro-mechanical systems for novel, life-saving medical devices. * Own the development of the embedded software/firmware for proof-of-concept devices and prototypes. * Dive into first generation firmware/software tests at the system, device, and component level for both design exploration and validation * Create detailed software/firmware functional specifications * Collaborate with cross-functional teams to support overall product development * Support product through pre & postproduction release including manufacturing & testing at contract manufacturers What You'll Bring * A passion and knack for solving hands-on and multi-disciplinary technical design problems * Proven ability to thrive in a fast-paced work environment where navigating grey areas is a welcomed challenge * BS in computer engineering/ software engineering/ electrical engineering or related field required * 1+ years of experience preferred * Hands-on experience developing prototype software/firmware for hardware such as PCB, Arduino, Raspberry Pi, or similar required * Programming experience required, proficiency in languages such as C or C++, and Python preferred * Embedded systems design, Unit testing, end to end testing on HW, communication protocols (SPI, UART, I2C, CAN, USB), Algorithm design, Signal Processing, Microcontrollers (STM32,ARM Cortex M4/M7 etc.), controls algorithm (ex. PWM, PID), RTOS and/or Bare metal * Familiarity with board bring up, logic analyzer, oscilloscope, Connectivity (BLE, Bluetooth, NFC, NFMI) preferred Working Conditions * General office environment. Business travel from 0% - 10%. Potential exposure to blood-borne pathogens. Requires some lifting and moving of up to 25 pounds. The employee is frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer, sitting for extended periods. Specific vision abilities required by this job include the ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception. Alameda, CAStarting Base Salary is $97,000/year - $127,000/year. Individual compensation will vary over time-based on factors such as performance, skill level, competencies, work location and shift. What We Offer * A collaborative teamwork environment where learning is constant, and performance is rewarded. * The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases. * A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s). Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws. If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents. For additional information on Penumbra's commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.
    $97k-127k yearly 60d+ ago
  • R&D Engineer II - Embedded Firmware

    Penumbra 4.4company rating

    Alameda, CA jobs

    As an R&D Engineer at Penumbra, you get to be hands-on, prototyping the next generation of medical devices! We are looking for someone who is excited about rolling up their sleeves to relentlessly iterate new ideas for electro-mechanical systems. You will work collaboratively to apply your passion for creative problem solving at all stages of the design process, from concept to commercialization, which will have a profound positive impact on patients worldwide.What You'll Work On Play a key role in early-stage development of the next generation of Penumbra products Be a pivotal team member for prototyping and designing electro-mechanical systems for novel, life-saving medical devices. Own the development of the embedded software/firmware for proof-of-concept devices and prototypes. Dive into first generation firmware/software tests at the system, device, and component level for both design exploration and validation Create detailed software/firmware functional specifications Collaborate with cross-functional teams to support overall product development Support product through pre & postproduction release including manufacturing & testing at contract manufacturers What You'll Bring A passion and knack for solving hands-on and multi-disciplinary technical design problems Proven ability to thrive in a fast-paced work environment where navigating grey areas is a welcomed challenge BS in computer engineering/ software engineering/ electrical engineering or related field required 1+ years of experience preferred Hands-on experience developing prototype software/firmware for hardware such as PCB, Arduino, Raspberry Pi, or similar required Programming experience required, proficiency in languages such as C or C++, and Python preferred Embedded systems design, Unit testing, end to end testing on HW, communication protocols (SPI, UART, I2C, CAN, USB), Algorithm design, Signal Processing, Microcontrollers (STM32,ARM Cortex M4/M7 etc.), controls algorithm (ex. PWM, PID), RTOS and/or Bare metal Familiarity with board bring up, logic analyzer, oscilloscope, Connectivity (BLE, Bluetooth, NFC, NFMI) preferred Working Conditions General office environment. Business travel from 0% - 10%. Potential exposure to blood-borne pathogens. Requires some lifting and moving of up to 25 pounds. The employee is frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer, sitting for extended periods. Specific vision abilities required by this job include the ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception. Alameda, CA Starting Base Salary is $97,000/year - $127,000/year. Individual compensation will vary over time-based on factors such as performance, skill level, competencies, work location and shift. What We Offer•A collaborative teamwork environment where learning is constant, and performance is rewarded.•The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.•A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s). Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws. If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents. For additional information on Penumbra's commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.
    $97k-127k yearly Auto-Apply 60d+ ago
  • Research and Development Engineer I/II

    Cresilon, Inc. 4.1company rating

    New York, NY jobs

    Job Description Cresilon is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company's proprietary hydrogel technology. The company's plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at ***************** Description: The R&D Engineer I/II is responsible for supporting product design and process development activities while ensuring compliance with all quality and regulatory requirements. The position has a scientific focus that includes implementation of formulation development through process development, prototype fabrication, and characterization, along with additional process evaluation and data generation through designed experiments. Process development in an R&D environment will be followed by qualification and technology transfer into manufacturing. Collaboration is a key aspect of this role, as the engineer will work within a multidisciplinary team of researchers and engineers. The position offers diverse opportunities in a collaborative cross-functional environment, requiring adaptability, flexibility, and a willingness to learn and innovate in the exploration of new technologies, new approaches, and techniques in pursuit of product/process robustness and innovation. The R&D Engineer I/II is expected to possess expertise in areas including, but not restricted to, polymer, chemical, material science, and process development and engineering. Additionally, they will assist in generating documentation essential for regulatory submissions, ongoing publication initiatives, and direct communication with the Head of Research regarding various tasks. This is a full-time, on-site position, located in Brooklyn, New York. This role is an independent contributor role (i.e. no direct reports). Level is dependent on experience. Responsibilities: Oversee the planning, implementation, and analysis of experiments relevant to project objectives. Ensure the application of established scientific and engineering principles to solve complex problems and challenges innovatively and efficiently, adhering to rigorous scientific methodologies and protocols. Create and execute product/process enhancement, and new product/process development plans. Lead material/design/process changes and their implementation with well-documented research/analyses. Process and analyze results, Author protocols and reports including engineering studies and design verification/validation activities. Aid in the development and execution of testing methods to aid in exploratory research, product/process development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes. Prepare samples as required for manufacturing, testing, or other evaluations and data analysis. Participate in voice-of-customer (VOC) labs and other user needs assessments. Interface with external vendors, customers, and suppliers. Specify equipment and process requirements for developing and implementing new products, product improvement and new equipment/processes. Support process and product transfers to manufacturing or CDMOs. Maintain a laboratory notebook and other technical documentation according to required GLP/GMP guidelines. Understand and prioritize process improvements, design experiments to make those improvements, and execute these plans in the laboratory. Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation about research towards FDA/regulated authority submissions. Provide support to the marketing and sales team, with the development of presentations, sales tools, and application data. Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization. Provide other project or product support as needed to support Cresilon's business objectives. Requirements Required Qualifications Education: BS in Chemical Engineering, Polymer Engineering, Material Science & Engineering, or related engineering discipline. Minimum 4+ years previous experience in an industrial environment with a BS degree. (2 years minimum experience if advanced degrees). Proficiency as an adept experimentalist with hands-on experience in the product and process development of polymeric materials and their characterization in an R&D or manufacturing environment. Mathematically inclined with strong analytical and problem-solving skills with the ability to be observant and to think creatively. Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies. Demonstrated ability to work independently as well as be a strong team contributor. Ability to effectively work within a team and cross-functionally to expedite the completion of critical project tasks. Requires understanding of product/process design and engineering. Experience should include process development/validation and/or transfer/verification, protocols, and troubleshooting skills. Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency on time. Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills. Working knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (cGMP) requirements. Proficiency in the use of Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft PowerPoint is required. Requires excellent written and verbal communication and presentation skills. Legal authorization to work in the United States is required. Physical Requirements include: Aseptic Gowning Qualification: Able to be successfully qualified for aseptic gowning, including successful respirator training. Wear Appropriate Personal Protective Equipment (PPE): Be able to stand and walk for prolonged periods, with the ability to climb, balance, stoop, bend, reach, and handle equipment. Ability to speak, listen, and understand verbal and written communication. Possesses hand-eye coordination and manual dexterity for delicate manipulations. Ability to lift up to 50 pounds occasionally and to carry, push, pull, or otherwise move objects. Visual acuity is required for performing close and distant activities. Preferred Qualifications An advanced technical degree (MS or PhD). ·Lab experience in an industry setting within cGMP-regulated environments. Prior experience developing processes and scaling these up into manufacturing or CDMO Mechanical/electrical knowledge with the ability to troubleshoot processing equipment Six Sigma green belt or black belt certification preferred. Experience implementing process and quality improvements in a manufacturing environment Work experience with the medical device or pharmaceutical industries Working knowledge of ISO 9001, ISO 13485:2003 and ISO 14971:200. Working knowledge of FDA requirements as per 21 CFR 820. Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits Competitive annual base salary range of $70,000 - $120,000, depending upon job level and qualifications Paid Vacation, Sick, & Holidays Monthly MetroCard Reimbursement 401(k) & Roth Retirement Savings Plan with company match up to 5% Work/Life Employee Assistance Program Company Paid Life and Short-Term Disability Coverage Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage
    $70k-120k yearly 15d ago
  • Research and Development Engineer I/II

    Cresilon Inc. 4.1company rating

    New York, NY jobs

    Cresilon is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company's proprietary hydrogel technology. The company's plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at ***************** Description: The R&D Engineer I/II is responsible for supporting product design and process development activities while ensuring compliance with all quality and regulatory requirements. The position has a scientific focus that includes implementation of formulation development through process development, prototype fabrication, and characterization, along with additional process evaluation and data generation through designed experiments. Process development in an R&D environment will be followed by qualification and technology transfer into manufacturing. Collaboration is a key aspect of this role, as the engineer will work within a multidisciplinary team of researchers and engineers. The position offers diverse opportunities in a collaborative cross-functional environment, requiring adaptability, flexibility, and a willingness to learn and innovate in the exploration of new technologies, new approaches, and techniques in pursuit of product/process robustness and innovation. The R&D Engineer I/II is expected to possess expertise in areas including, but not restricted to, polymer, chemical, material science, and process development and engineering. Additionally, they will assist in generating documentation essential for regulatory submissions, ongoing publication initiatives, and direct communication with the Head of Research regarding various tasks. This is a full-time, on-site position, located in Brooklyn, New York. This role is an independent contributor role (i.e. no direct reports). Level is dependent on experience. Responsibilities: * Oversee the planning, implementation, and analysis of experiments relevant to project objectives. Ensure the application of established scientific and engineering principles to solve complex problems and challenges innovatively and efficiently, adhering to rigorous scientific methodologies and protocols. * Create and execute product/process enhancement, and new product/process development plans. * Lead material/design/process changes and their implementation with well-documented research/analyses. Process and analyze results, * Author protocols and reports including engineering studies and design verification/validation activities. * Aid in the development and execution of testing methods to aid in exploratory research, product/process development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes. * Prepare samples as required for manufacturing, testing, or other evaluations and data analysis. * Participate in voice-of-customer (VOC) labs and other user needs assessments. * Interface with external vendors, customers, and suppliers. Specify equipment and process requirements for developing and implementing new products, product improvement and new equipment/processes. * Support process and product transfers to manufacturing or CDMOs. * Maintain a laboratory notebook and other technical documentation according to required GLP/GMP guidelines. * Understand and prioritize process improvements, design experiments to make those improvements, and execute these plans in the laboratory. * Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation about research towards FDA/regulated authority submissions. * Provide support to the marketing and sales team, with the development of presentations, sales tools, and application data. * Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization. * Provide other project or product support as needed to support Cresilon's business objectives.
    $81k-113k yearly est. 5d ago
  • R&D Engineer I

    Penumbra Inc. 4.4company rating

    Alameda, CA jobs

    The Research and Development Engineer I engineers, designs, and develops new products or changes to existing products, processes, and equipment. Performs testing, implementation, and documentation of engineering changes. Uses both theoretical and practical solution development through the application of scientific and design of experiment processes. Specific Duties and Responsibilities * Assist in design, development, and testing of Penumbra, Inc. products* * Create engineering test protocols* * Run and report engineering tests* * Design fixtures and tooling to facilitate prototype assembly and material testing * Evaluate prototypes against standards or specifications and troubleshoot problems to assess root cause and corrective action * Interpret and communicate test results* * Solve practical problems encountered* * Document findings and recommendations* * Present findings to project managers* * Adhere to the Company's Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. * * Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. * * Ensure other members of the department follow the QMS, regulations, standards, and procedures. * * Perform other work-related duties as assigned. * Indicates an essential function of the role Location and Salary Alameda, CA $80,000 to $105,000 Position Qualifications Minimum education and experience: * Bachelor's degree in Engineering, Physical Sciences or related technical field or equivalent combination of education and experience. Additional qualifications: * Medical device industry experience desired * Verbal, analytical, computer and hands-on laboratory skills required Working Conditions * General office, production, laboratories, and controlled environment facility. * Potential exposure to blood-borne pathogens. * Requires some lifting and moving of up to 25 pounds. * Must be able to move between buildings and floors. * Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day. * Must be able to read, prepare emails, and produce documents and spreadsheets. * Must be able to move within the office and access file cabinets or supplies, as needed. * Must be able to communicate and exchange accurate information with employees at all levels on a daily basis. What We Offer * A collaborative teamwork environment where learning is constant, and performance is rewarded. * The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases. * A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s). Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws. If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents. For additional information on Penumbra's commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.
    $80k-105k yearly 51d ago

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