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Process Development Engineer jobs at Regeneron - 831 jobs

  • Senior Manufacturing Process Engineer & Validation Leader

    Boston Scientific Gruppe 4.7company rating

    Boston, MA jobs

    A leading medical technology company is seeking a Manufacturing Engineer II in Boston to oversee manufacturing operations and documentation. The ideal candidate will have 5-7 years of experience in engineering, strong analytical abilities, and effective communication skills. This position involves working in a fast-paced environment and requires a Bachelor's degree in Engineering. Opportunities for project management and international travel are available. #J-18808-Ljbffr
    $85k-103k yearly est. 4d ago
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  • Senior Manufacturing Engineer: Medical Device Processes

    Boston Scientific Gruppe 4.7company rating

    Boston, MA jobs

    A global medical technology leader is seeking a Senior Manufacturing Engineer to perform manufacturing engineering duties. The ideal candidate should possess strong analytical skills and at least 8 years of experience in a related field, preferably in the medical device industry. Responsibilities include overseeing key process equipment, developing manufacturing documentation, and training team members. Join a company dedicated to transforming lives through innovative medical solutions. #J-18808-Ljbffr
    $85k-103k yearly est. 1d ago
  • Senior Manufacturing Engineer II - Process & Quality Leader

    Boston Scientific Gruppe 4.7company rating

    Boston, MA jobs

    A global medical technology leader is seeking a Manufacturing Engineer II to perform various engineering duties, including developing manufacturing documentation and ensuring product quality. The ideal candidate will have a Bachelor's degree in Engineering and 5-8 years of relevant experience, possessing strong analytical, problem-solving, and leadership skills. This role involves cross-functional collaboration, training team members, and achieving production goals. Join us to make a difference in patient health. #J-18808-Ljbffr
    $85k-103k yearly est. 20h ago
  • Senior Manufacturing Engineer

    Boston Scientific Gruppe 4.7company rating

    Boston, MA jobs

    Manufacturing Engineering Department seeks a Senior Manufacturing Engineer to perform all manufacturing engineering duties. Ideal candidate possesses effective verbal, written, presentation, negotiation, and interpersonal skills. Demonstrates ability to generate manufacturing documentation, specifications, and technical reports in a concise manner, hands‑on, action‑oriented with strong analytical and critical thinking skills. Job Responsibilities Identify, order, and commission key process equipment to CGMP in the Operations Engineering Cycle to meet key business objectives. Serve as engineering process owner for the area. Develop and modify manufacturing documentation and procedures to support commercial products and introduce new products to the production floor (assembly procedures, BOMs, etc.). Ensure that new products introduced to the production floor meet business, quality, output, and cost goals and objectives. Develop and modify various manufacturing processes to improve product and process quality and output. Ensure product/process requirements are met for component, assembly, tooling, and supplier specifications. Support material discrepancy review and disposition activities (MRB) for existing commercial products. Become a recognized leader or authority in an area of specialization and apply this knowledge in leadership roles in the company. Eliminate or reduce product/process defects and improve yields; solve problems from basic engineering principles. Demonstrate a primary commitment to patient safety and product quality. Support all quality and corrective/preventive actions initiatives (NCEP, CAPA) to achieve quality goals. Maintain a valid capacity model in cooperation with the line supervisor and conduct adequate advance planning for required capital. Capable of training cross‑functional team members, including engineers, technicians, and product builders. Possess knowledge of project management. Interact cross‑functionally with internal and external customers. Develop expert knowledge on BSC systems. Willing to travel internationally as part of a project team. Calibration Engineering Role Provide equipment calibration services necessary to meet company objectives while assuring measurement traceability to nationally recognized equipment calibration standards and practices. Technical SME for Calibration group and SME for internal and external audit. SME for Calibration Management System. Perform calibration functions and set day‑to‑day functions for the calibration group. Research and recommend new standards and capital equipment, providing detailed justifications and cost analysis. Develop technical engineering reports and complex technical calibration procedures; train department technicians on new calibration procedures. Work directly with Equipment Engineering and Manufacturing Engineering departments to advise on equipment selection, design accommodations for calibration of new equipment, and appropriate measurement techniques. Provide support and guidance to calibration technicians in performing complex equipment calibrations. Support calibration laboratory needs regarding environmental control and new technologies. Work with management to develop the department fiscal year budgets. Communicate with the Operations ME function on calibration status. Build quality into all aspects of work by maintaining compliance to all quality requirements. Drive “Standard Work” in all aspects of calibration activity. Job Requirements At least a Bachelor's degree in Mechanical Engineering (preferably in mechanical, chemical, or biomedical). Minimum 8 years of experience in a related field. Preferable experience in the medical device or other regulated industry. Leadership experience. Strong engineering knowledge, problem‑solving skills. Experience sustaining and production working environments. Collaborative with cross‑functional teams. Experience in the medical devices manufacturing industry is a plus. About Us As a global medical technology leader for more than 40 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve patient health. If you're looking to truly make a difference to people both around the world and around the corner, there's no better place to make it happen. Job Segment Biomedical Engineering, Manufacturing Engineer, Medical Device, Medical Device Engineer, Chemical Research, Engineering, Healthcare #J-18808-Ljbffr
    $79k-96k yearly est. 1d ago
  • Manufacturing Engineer (Mid Senior)

    Boston Scientific Gruppe 4.7company rating

    Boston, MA jobs

    Manufacturing Engineering Department seeking a Manufacturing Engineer II to perform all manufacturing engineering duties. The ideal candidate must possess effective verbal, written presentation, negotiation and interpersonal skills. Demonstrate ability to generate manufacturing documentations, specifications and technical reports in a concise manner, hands on and action oriented engineer with strong analytical, critical thinking skills and able to work well under general directions with minimum supervision. The candidate should be data driven, goal oriented and willing to learn and development new skills, able to work in a fast paced, time sensitive, multi-project and results driven environment with multi-disciplinary team interface. The ideal candidate must be able to plan and organize non-routine task. Job Description To identify, order and commission the key process equipment to CGMP in the Operations Engineering Cycle to meet key business objectives Engineering process owner for the area Develop and modify manufacturing documentation and procedures to support commercial products as well as the introduction of new products to the production floor (assembly procedures, BOMs, etc.) Ensure that new products introduced to the production floor meet business, quality, output and cost goals and objectives Develop and modify various manufacturing processes to improve product and process quality and output Ensure product/process requirements are met for component, assembly, tooling and supplier specifications Support material discrepancy review and disposition activities (MRB) for existing commercial products Develops knowledge in a field to become a recognized leader or authority in an area of specialization and applies this knowledge in leadership roles in the company Eliminate/reduce product/process defects and improve yields. Strong problem solver for technical problems in the area, solves problems from basic engineering principles, theories and concepts. Support all quality and corrective/preventive actions initiatives (NCEP, CAPA) to achieve quality goals Capable of training cross functional team members including engineers, technicians and product builders Knowledge of project management Interacts cross functionally and with internal and external customers Ability to develop expert knowledge on BSC systems Willing to travel internationally as part of project team Calibration Engineering Responsibilities For individual who is assigned calibration engineering role only: Provide equipment calibration services necessary to meet company objectives, while assuring measurement traceability to nationally recognized equipment calibration standards and practices. Technical SME for Calibration group and SME for internal and external Audit SME for Calibration Management System Manage and Perform calibration functions. Sets day to day function for calibration group Researches, recommends, and acquires new standards and other capital equipment, providing detailed justifications and cost analysis as required. Develops technical engineering reports and complex technical calibration procedures and trains department technicians on new calibration procedures. Works directly with Equipment Engineering and Manufacturing Engineering departments to advise on equipment selection, design accommodations for calibration of new equipment and appropriate measurement techniques. Provides support and guidance to calibration technicians in performing complex equipment calibrations. Manage calibration lab needs regarding such issues as environmental control and new technologies. Works with Senior Metrology Engineer and Management to develop the department fiscal year budgets. Communicates with the Operations ME function on calibration status. Build Quality into all aspects of work by maintaining compliance to all quality requirements Job Requirements Candidate required possess at least Bachelor's Degree in Engineering. Required at least 5 ~ 8 years of working experience in related field. Prefer candidate with possesses hands-on experience in manufacturing and process engineering, with a proven track record in problem-solving and process improvement. Additional advantage includes experience in people management. Skill required: Strong analytics skill, problem Solving and Process Improvement knowledge and leadership skill. About Us As a global medical technology leader for more than 40 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you're looking to truly make a difference to people both around the world and around the corner, there's no better place to make it happen. Job Segment Manufacturing Engineer, Project Manager, Business Process, Industrial, Engineering, Technology, Management, Manufacturing #J-18808-Ljbffr
    $79k-96k yearly est. 20h ago
  • Manufacturing Engineer (CSV)

    Mentor Technical Group 4.7company rating

    San Francisco, CA jobs

    Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Responsibilities Engineering Experience in Medical Device Industry Problem Solving Knowledge (Yellow or Green Belt knowledge) Responsibilities may include the following and other duties may be assigned. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations. Qualifications Requirements/Knowledge/Education/Skills BBA in Engineering Knowledge in CSV Problem Solving Knowledge (Yellow or Green Belt knowledge) Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. #J-18808-Ljbffr
    $85k-111k yearly est. 20h ago
  • CSV Manufacturing Engineer | Life Sciences & Med Device

    Mentor Technical Group 4.7company rating

    San Francisco, CA jobs

    A leading technical solutions provider is seeking an engineer specialized in the medical device industry. The role involves designing manufacturing processes and ensuring compliance with safety regulations. Candidates should have a BBA in Engineering, knowledge in CSV, and problem-solving skills (Yellow or Green Belt). The position offers an opportunity to work with innovative technologies in a dynamic environment located in Caguas, Puerto Rico. #J-18808-Ljbffr
    $85k-111k yearly est. 20h ago
  • Materials Engineer

    Veridiam 4.2company rating

    El Cajon, CA jobs

    Veridiam is a strategic manufacturing partner specializing in precision fabrication of components and assemblies made from exotic metals for critical applications in aerospace, defense, medical, nuclear, and space. Our roots were formed in the exacting nuclear and aerospace industries, expanded into medical where we have supplied critical components to a global customer base. Veridiam's ability to work with challenging materials such as titanium alloys, nickel-based superalloys, refractory metals, and specialty stainless steels ensures reliable, mission-ready products for our customers' most vital programs. As a trusted partner, Veridiam provides technical collaboration, quality assurance, and supply chain reliability essential to advancing innovation and operational success across these highly regulated industries and results for mission-critical parts made from titanium alloys, nickel-based superalloys, refractory metals and more. At Veridiam we recognize that talent is at the forefront of our organization and define who we are in today's industry. You will work in a highly regulated, precision manufacturing environment where safety, documentation integrity, dimensional control (“True Diameter”) and traceability are paramount. Veridiam is looking for a Materials Engineer for our El Cajon facility. Interested candidates should apply directly to our website at: Careers - Strategic Manufacturing Partner > Veridiam Position Summary Extract, research, develop, test, and improve materials used in our products and processes. Perform tests and conduct research on properties, performance and applications of metals including high-performance alloys. Analyze material behavior under various conditions and prepare technical reports. Essential Duties and Responsibilities Perform assigned routine and advanced or complex tests on raw material, product in process, re-worked material, finished goods and/or developmental samples in accordance with customer and/or quality standards/specifications. Conduct research on the properties, performance, and applications of metals including high-performance alloys such as stainless steel, titanium, and nickel alloys. Develop and test new materials to improve product durability, performance, and efficiency. Perform failure analysis and recommend design/material improvements. Analyze material behavior under various conditions (stress, temperature, corrosion, wear, etc.). Review and manage internal and external material lab test results. Develop and maintain processes for new product introduction. Prepare technical reports, specifications, and documentation for internal and customer use. Prepare, organize, and maintain necessary samples, forms, documentation and trend charts. May provide data and analysis to material review board to support resolution of issues, initial data support to supplier and/or customer notification. Ensure compliance with industry standards, safety regulations, and environmental requirements. Support process optimization and cost-reduction initiatives without compromising quality. Work collaboratively with cross-functional teams to ensure materials meet customer requirements and performance, quality and cost objectives. Provide and supply training for others in the area. Maintain clean and orderly work environment. Demonstrates ability to appear for work on time, follow directions from a supervisor, interact well with co-workers, understand and follow work rules and procedures, comply with company policies and procedures, goals and objectives, and accepts constructive feedback. Other duties as assigned, requested or needed. Position Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions. Education and Experience: Bachelor's degree in Materials Science, Materials Engineering, Metallurgy, Chemical Engineering or related field. Five (5) or more years' experience in manufacturing and/or familiarity of the international standards for testing metallic materials (ASTM E8) including steel products (ASTM A370) preferred or equivalent education and experience. Knowledge, Skills, and Abilities: Knowledge of metal forming, and/or machining methods preferred. Excellent written and verbal communication skills. Ability to read and interpret documents such as work orders, operating and maintenance instructions and procedure manuals and blueprints. Ability understand and follow standard operating and safety procedures. High-level attention to detail and commitment to quality standards. Strong problem-solving skills and technical expertise in materials science. The above statements are intended to describe, in broad terms, the general functions and responsibility levels assigned to this classification. Management has the right to change duties at any time to meet business needs. Pay Rate: The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience with the industry, education, geographic location, etc. Veridiam is an Equal Employment Opportunity/Affirmative Action Employer. Veridiam will recruit, hire, train and promote persons into all jobs without regard to age, race, color, religion, ancestry, medical condition, sex, sexual orientation, gender identity, national origin, status as a veteran or status as an individual with a disability or any other characteristic or classification protected by law. Access to our facility (and, therefore, employment) is restricted under the International Traffic in Arms Regulations (ITAR) and/or Export Administration Regulations (EAR) to U.S. Citizens, lawful permanent residents of the United States and properly licensed foreign persons. Applicants receiving a conditional offer of employment will be required to provide information to determine whether they are subject to these regulations and, if so, to assess their country of chargeability for export control purposes.
    $77k-104k yearly est. 3d ago
  • CSV Manufacturing Engineer | Life Sciences & Med Device

    Mentor Technical Group 4.7company rating

    Boston, MA jobs

    A leading technical solutions provider is seeking an engineer specialized in the medical device industry. The role involves designing manufacturing processes and ensuring compliance with safety regulations. Candidates should have a BBA in Engineering, knowledge in CSV, and problem-solving skills (Yellow or Green Belt). The position offers an opportunity to work with innovative technologies in a dynamic environment located in Caguas, Puerto Rico. #J-18808-Ljbffr
    $73k-93k yearly est. 20h ago
  • Manufacturing Engineer (CSV)

    Mentor Technical Group 4.7company rating

    Boston, MA jobs

    Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Responsibilities Engineering Experience in Medical Device Industry Problem Solving Knowledge (Yellow or Green Belt knowledge) Responsibilities may include the following and other duties may be assigned. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations. Qualifications Requirements/Knowledge/Education/Skills BBA in Engineering Knowledge in CSV Problem Solving Knowledge (Yellow or Green Belt knowledge) Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. #J-18808-Ljbffr
    $73k-93k yearly est. 20h ago
  • Principal Manufacturing Engineer

    Olympus Corporation of The Americas 4.6company rating

    Minneapolis, MN jobs

    Workplace Flexibility: Onsite For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives. Our five Core Values empower us to achieve Our Purpose: Patient Focus, Integrity, Innovation, Impact and Empathy. Learn more about Life at Olympus. Job Description Provide technical leadership and serve as the operations engineering lead on cross-functional product development teams with a focus on driving cost reduction, manufacturability improvements, and value-added solutions for manufacturing operations. This role will directly influence design decisions and operational strategies to ensure products are developed with an optimized cost structure, robust manufacturing processes, and alignment to business goals for efficiency, quality, and profitability. Partner closely with R&D, Supply Chain, Quality, and Operations to ensure that new products and design changes deliver measurable improvements to cost, manufacturability, and operational performance. Leverage extensive technical expertise and business acumen to lead initiatives from concept through commercialization. Job Duties Act as the primary Operations Engineering Lead on product development projects, driving alignment between design decisions and manufacturing strategies to optimize cost, quality, and operational performance. Identify, evaluate, and implement new manufacturing processes, equipment, and technologies to improve efficiency, reduce waste, and enhance product quality. Identify and deliver opportunities for cost savings and operational efficiency through process improvements, materials selection, and innovative manufacturing solutions. Collaborate with suppliers, equipment manufacturers, and internal engineering resources to deliver optimized manufacturing solutions. Drive system changes (GWIs, GSOP forms) and business systems (Line Balance, work content tools) Lead development of validation documentation (IQ, OQ, PQ) Develop programs for training operations and engineering (Knowledge Sharing) Develop and implement discussions with resources such as suppliers and Olympus sites to develop new business opportunities Lead assessment strategy for process capabilities, prioritize process improvement opportunities. Innovate and lead process improvement activities Leadership of regional cross functional high visibility projects Follows GWI's, GSOP and owns MP's to ensure control of product/process design Other duties as assigned Job Qualifications Required: A minimum of a Bachelor's degree (B.S.) in science/engineering or equivalent discipline. Minimum of 10 years with varying technical experience. Strong business acumen, operations metrics understanding with proven process improvement examples, strong project management and mentoring of less experienced engineering teams. Ability to effectively communicate up and down within the OSTA organization. Up to 10% percent international and domestic travel. Why join Olympus? We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture. Equitable Offerings you can count on: Competitive salaries, annual bonus and 401(k)* with company match Comprehensive medical, dental, vision coverage effective on start date 24/7 Employee Assistance Program Free live and on-demand Wellbeing Programs Generous Paid Vacation and Sick Time Paid Parental Leave and Adoption Assistance* 12 Paid Holidays On-Site Child Daycare, Café, Fitness Center** Connected Culture you can embrace: Work-life integrated culture that supports an employee centric mindset Offers onsite, hybrid and field work environments Paid volunteering and charitable donation/match programs Employee Resource Groups Dedicated Training Resources and Learning & Development Programs Paid Educational Assistance *US Only **Center Valley, PA and Westborough, MA Are you ready to be a part of our team? Learn more about our benefit and incentives. The anticipated base pay range for this full-time position working at this location is $114,467.00 - $160,254.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications. At Olympus, we are committed to Our Purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world. Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit *********************** You Belong at Olympus We value a workforce that reflects a wide range of perspectives, backgrounds, and experiences. We foster an environment where all employees feel valued, respected, and supported. And we provide employees with equal access to opportunities for growth and development. Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact [email protected]. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-###-####). Let's realize your potential, together. It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law. Posting Notes: || United States (US) || Minnesota (US-MN) || Brooklyn Park || Manufacturing & Repair
    $114.5k-160.3k yearly 6d ago
  • Quality Engineer - Temporary

    Bio-Rad Laboratories 4.7company rating

    Hercules, CA jobs

    The Quality Engineer will help facilitate the updating and consolidation of legacy product risk management files related to IVDR. How You'll Make An Impact: Facilitating risk management assessments, updating risk plans and reports, consolidation and updating product system hazard analysis files in accordance with established company procedures and applicable standards Coordinate and facilitate meetings with cross functional stakeholders as needed to obtain information and data needed for completeness and accuracy of risk profiles for existing hazards, and identification of new risks and hazards as needed. Escalate events to Management that require additional inputs or mitigations. Support product risk management file migration into the eQMS system including ensuring document meta data is accurate and files are accurately linked to legacy product DHF binders in coordination with DHF migration efforts. Assessing legacy risk documentation and identifying gaps against initial IVDR transitional activities versus new guidance documents and updates to global risk management procedures. Support other IVDR related technical documentation updates and gap assessments as required, including migration into eQMS as needed. Ability to work in an ever-shifting environment and possess a high level of patience to support cross functional teams with shifting priorities. A self-starter who can work independently and possesses a sense of ownership and accountability to the activities assigned to them. What You Bring: Bachelor's degree or equivalent in a related technical or engineering discipline 2-3 years experience or equivalent combination of education and experience General knowledge of and application of principles and theories of quality engineering and risk management. Understanding of Medical Device/GMP/ISO regulations (ISO 14971, ISO 13485, MDSAP and FDA CFR Part 820), and FDA CFR Part 210/211 preferred. General understanding of risk management regulations, principles, and application. Excellent critical thinking, problem solving, coordination, teamwork, communication, technical and computer skills. SAP, EtQ and/or Veeva experience a plus. Proficient in Microsoft Office, Visio Compensation: The estimated hourly range for this position is $40.38 to $55.76 per hour at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. As a temporary associate, your employment will be managed directly through our approved agency provider. Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see. EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply. Agency Non-Solicitation:Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes Fraud Alert: Bio-Rad has received reports of individuals posing as Bio-Rad recruiters to obtain information, including personal and financial, from applicants. Beware of these fake "recruiters" and job scams. Click here for more information on this scam and how to avoid it. Legal Entity: (USA_1000) Bio-Rad Laboratories, Inc.
    $40.4-55.8 hourly 1d ago
  • Senior Manufacturing Engineer

    Olympus Corporation of The Americas 4.6company rating

    Minneapolis, MN jobs

    Workplace Flexibility: Onsite For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives. Our five Core Values empower us to achieve Our Purpose: Patient Focus, Integrity, Innovation, Impact and Empathy. Learn more about Life at Olympus. Job Description Provide technical leadership and mentorship within the Manufacturing Engineering function, with a primary focus on the development, implementation, and continuous improvement of automated production equipment and systems. This role requires a strong background in mechanical, pneumatic, electrical, PLC, and vision systems, and the ability to lead complex automation initiatives from concept through deployment. Act as a representative of Manufacturing Engineering to support new product introduction and manufacturing automation strategies, ensuring alignment with business objectives. May have direct technician reporting structure. May influentially lead engineers. Job Duties Drive operations and new product/process development activities Lead the design, development, and implementation of automated production equipment and manufacturing systems, ensuring solutions meet operational performance, quality, and safety requirements. Provide technical expertise in mechanical design, pneumatics, electrical systems, PLC programming, and machine vision technologies to support automation initiatives. Drive system changes (GWIs, GSOP forms) and business systems (Line Balance, work content tools) Mentor/Lead the validation of equipment and processes as required (IQ, OQ, PQ) Mentor and implement capacity planning, cost improvement and facilities layout for equipment moves and additions Perform operator training for new and existing processes Lead discussions with resources such as suppliers and Olympus sites to resolve technical issues or improve processes or products Assess process capabilities, prioritize process improvement opportunities. Innovate and implement process improvement activities Leadership of cross functional project teams Review prints for new and existing products Follows GWI's, GSOP and owns MP's to ensure control of product/process design Other duties as assigned Job Qualifications Required: A minimum of a Bachelor's degree (B.S.) in science or engineering discipline. Minimum of 5 years' experience. Applied experience using LEAN and Six Sigma tools. Leadership and mentoring capabilities with statistical analysis. Ability to work well/Lead multiple cross functional teams. Proficient technical writing skills. Experience with leading risk management documentation. Proficient time management skills. Demonstrated fixture and tooling experience. CAD experience. Supervision of technical resources. Why join Olympus? We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture. Equitable Offerings you can count on: Competitive salaries, annual bonus and 401(k)* with company match Comprehensive medical, dental, vision coverage effective on start date 24/7 Employee Assistance Program Free live and on-demand Wellbeing Programs Generous Paid Vacation and Sick Time Paid Parental Leave and Adoption Assistance* 12 Paid Holidays On-Site Child Daycare, Café, Fitness Center** Connected Culture you can embrace: Work-life integrated culture that supports an employee centric mindset Offers onsite, hybrid and field work environments Paid volunteering and charitable donation/match programs Employee Resource Groups Dedicated Training Resources and Learning & Development Programs Paid Educational Assistance *US Only **Center Valley, PA and Westborough, MA Are you ready to be a part of our team? Learn more about our benefit and incentives. The anticipated base pay range for this full-time position working at this location is $93,793.00 - $126,621.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications. At Olympus, we are committed to Our Purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world. Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit *********************** You Belong at Olympus We value a workforce that reflects a wide range of perspectives, backgrounds, and experiences. We foster an environment where all employees feel valued, respected, and supported. And we provide employees with equal access to opportunities for growth and development. Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact [email protected]. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-###-####). Let's realize your potential, together. It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law. Posting Notes: || United States (US) || Minnesota (US-MN) || Brooklyn Park || Manufacturing & Repair
    $93.8k-126.6k yearly 6d ago
  • Manufacturing Engineer

    Fresenius Kabi USA, LLC 4.7company rating

    Grand Island, NY jobs

    Job SummaryResponsible for engineering project execution by cross functional team of internal and external subject matter experts to improve plant performance, capacity and quality. Under the guidance of the Manager of Engineering or Senior Manufacturing Engineer, the primary responsibility of this position is for design modifications to existing high-speed pharmaceutical manufacturing equipment and tooling in order to improve quality, optimize performance and minimize defects. This position will also be responsible for specifying and procuring new equipment and tooling, managing equipment and facilities projects from conception through completion, including determining and meeting change control requirements. Excellent written and verbal communication skills. Excellent project management skills including experience using MS Project. Experienced AutoCAD or SolidWorks user. Maintain cGMP compliance in accordance with worldwide guidance sources. Salary Range: $60,966-$85,694 annually Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.Responsibilities Investigates current equipment performance to identify problems and solutions. Working with operators, quality assurance, and maintenance, identifies and implements necessary improvements. These may include modifications to machine design, tooling, and components. Prepares, writes and executes Risk Analysis (FMEA, Fishbone Diagrams) and Engineering Change Requests. Prepares and executes User Requirement Specifications, Functional Requirement Specifications, Design Specifications/Qualifications, Factory and Site Acceptance Tests, Machinability Studies and Standard Operating Procedures as necessary for new and modified equipment. Prepares funding requests per corporate guidelines, including detailed project descriptions, backgrounds, sketches, alternatives, financial data, justifications, quotations, estimates and schedules. Oversees the installation of equipment and facility modifications. Performs vendor selection, budgeting, procurement of equipment or services, scheduling, vendor coordination, rigging, set-up, training, start-up, and troubleshooting. Prepares and executes validation protocols. Assists Manufacturing and Maintenance with solving problems, improving processes and reducing costs. Maintains compliance with regulatory agency guidance and Fresenius Kabi procedures. Responsible for maintaining automated and controlled systems for manufacturing equipment. Rotating on-call availability for off-shift hours for manufacturing support. Requirements Bachelor degree and 1-3 years' experience in a similar discipline required. Experience with high-speed manufacturing machinery design and operation preferred. Working knowledge of project management and experience using MS Project preferred. Understanding of plant mechanical and electrical systems, as well as the ability to read construction and process drawings preferred. Must have excellent problem solving and communications skills. Experience with AutoCAD and/or SolidWorks preferred. Computerized and automation control system familiarity strongly preferred. Familiarity with FDA or other regulated industry preferred. Must have an engineering/technical background. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
    $61k-85.7k yearly 3d ago
  • Quality Engineer I - Temporary

    Bio-Rad Laboratories 4.7company rating

    Woodinville, WA jobs

    Join Bio-Rad as our Quality Engineer and work in our Woodinville, WA site! Working in this Quality Assurance role, you will attend cross functional Daily Management meetings and represent Quality Assurance following up on blocking issues and implementing counter measures. You will manage the Material Review Board and ensure thorough data-driven documentation of non-conformities and risk based determination of CAPA. You will review data for trends, manage corrections and corrective action and support Global Supply Chain and business partners as requested. How You'll Make An Impact: Support release of high-quality product by managing the Material Review Board and making risk-based and compliant decisions. Maintain the integrity of the Quality Management System by ensuring investigations are well designed, executed and documented. Provide confidence to internal and external customers by following through on actions, continually improving processes, and promoting quality culture. Demonstrate focus and accountability by attending Daily Management and consistently meeting commitments with timeliness and reliability. Facilitate risk management practices and ensure all quality requirements are satisfied. What You Bring: Bachelor's degree or equivalent in a related scientific discipline. 0-2+ years experience or equivalent combination of education and experience. Ability to apply GMP / ISO regulations and validation principles in a regulated manufacturing environment preferred. Basic understanding of risk management best practices and regulations for the medical device industry. Quality Engineering, Six Sigma Green Belt Certifications desirable. Skilled in statistical methods, statistical process control and experimental design preferred. Ability to work well in fast paced and cross-functional teams. Compensation: The estimated hourly for this position is $38.54 to $43.73 per hour at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. As a temporary associate, your employment will be managed directly through our approved agency provider. Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives.Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see. EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply. Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes. Fraud Alert: Bio-Rad has received reports of individuals posing as Bio-Rad recruiters to obtain information, including personal and financial, from applicants. Beware of these fake "recruiters" and job scams. Click here for more information on this scam and how to avoid it. Legal Entity: (USA_1000) Bio-Rad Laboratories, Inc.
    $38.5-43.7 hourly 1d ago
  • Quality Engineer I

    Biomerieux Inc. 4.7company rating

    Philadelphia, PA jobs

    The Quality Engineer in the Global Industrial Applications Pre & Post Market Quality team will be fully involved in managing quality processes during product development as well as during the product lifecycle.Primary Duties: Monitor a product portfolio intended to food and/or pharmaceutical industrial diagnostic (reagents, instruments, software; microbiology, molecular biology, immunology); as such, you will be: Member of the project teams for developing or modifying these products. The preferred contact and the guarantor of the quality processes implemented throughout the product lifecycle (such as design control, design change management, field actions management), in accordance with bio Merieux, international and customer requirements. Pilot and ensure that product risk management is controlled all along the product lifecycle. Be able to challenge and to propose alternatives on technical and strategic choices and decisions made in the projects, with regards to risk-taking on quality and business aspects; be able to escalate wisely. Manage the organization of Field Action Board meetings in charge of deciding on the actions to be taken in the field in the event of problems with the marketed products; as such, you will interface with GiCS (global industry customer service) representatives, manufacturing site quality manager, program directors and Industrial Applications Quality Managers. Be the preferred contact for other functions, on quality processes for your product ranges. Support the teams for audit preparation and be the preferred audit contact for quality purposes about development and field actions on your product portfolio. Contribute to improving the product lifecycle efficiency or any quality process required within the Industry Unit; as such, you will coordinate or contribute to continuous improvement initiatives as well for your ranges as for overall practices harmonization, interfacing with other professions. Perform all work in compliance with company quality procedures and standards. Minimum Qualifications: Bachelors degree in a Scientific field required. Master's degree preferred. 2 years' experience in Quality or Research and Development Including expereince in PCR, molecular biology, microbiology techniques and diagnostic product development. Industry experience preferred. Quality job and design control for the development of reagents and/or instruments experience is preferred. Knowledge, Skills and Abilities: Knowledge of standards applicable to design control and to pharma and/or food field (ISO 9001, ISO 13485, ISO 14971, 21CFR820, GAMP, 21CFR11, GMPs, ISO 16140 ...) and the capacity to act as a quality auditor. Knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, IVDR, AFNOR etc.). Knowledge of the industrial domain is strongly expected (pharmaceutical, cosmetic, food industries) Experience in participation in the management of regulatory audits (i.e. ISO 9001,ISO 13485, FDA, etc.). Manage and meet competing deadlines, requiring careful prioritization and time management to ensure all tasks are completed on time. Understand complex information and interpret it accurately, often requiring critical thinking and analysis to grasp the full picture. Effectively deal with ambiguity requiring adaptability, critical thinking, and proactive communication to navigate situations with limited details Informing others by sharing clear, timely information to ensure alignment. Functional skills including critical thinking, adaptability, time management, communication, problem-solving and digital literacy. Critical thinking, using logic and reason to analyze information and make decisions in the workplace Managing and measuring work by tracking progress, performance, and goal achievement using metrics and KPIs. Communicates instructions clearly and effectively Ability to work cross-functionally allowing for better collaboration and communication when working across teams to achieve shared objectives Ability to cooperate with others at all levels including leadership Consistently uphold and reflects the core ethical principles and values that bio Merieux promotes Domestic and International travel - 5%The estimated salary range for this role is between $77,900 - $98,700. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bio Merieux's bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate's experience and will be presented in writing at the time of the offer.In addition, bio Merieux offers a competitive Total Rewards package that may include: A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options Company-Provided Life and Accidental Death Insurance Short and Long-Term Disability Insurance Retirement Plan including a generous non-discretionary employer contribution and employer match. Adoption Assistance Wellness Programs Employee Assistance Program Commuter Benefits Various voluntary benefit offerings Discount programs Parental leaves #LI-US#biojobs Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bio Merieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bio Merieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site or contact us at [emailprotected]. BioMerieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMerieux's or its affiliates' application process by contacting us via telephone at , by email at [emailprotected], or by dialing 711 for access to Telecommunications Relay Services (TRS).
    $77.9k-98.7k yearly 1d ago
  • Staff Process Development Engineer

    Dexcom, Inc. 4.7company rating

    San Diego, CA jobs

    The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Meet the team: You will be part of the Global Engineering team within Operations, tasked with end-to-end technical oversight of our manufacturing technologies spanning our suppliers, contract manufactures, automation houses, and internal manufacturing. Including providing technical support for on-market production at our manufacturing sites. You will bring your expertise and passion for the development, qualification, validation and change management of complex manufacturing automation equipment, working closely in cross-functional teams to integrate cutting-edge technology into our manufacturing processes. You will ensure high efficiency, precision, and quality in Operations. You will play a pivotal role in ensuring robust new product introduction, capacity expansion, and sustained on-market performance. This crucial role supports Dexcom's thrilling growth trajectory in delivering essential, life-changing products to our valued customers. As part of this dynamic and highly effective team, you will collaborate closely across multiple functions, gaining broad exposure to our entire product life cycle. Where you come in: * You are a global engineering lead, managing execution of program deliverables that focus on both design/process changes to existing on Market product as well as new product development. Deliverables span from proof of concept to pilot manufacturing, to global high volume commercial automation. * You will lead process development strategy, design of experiments and measurement system analyses to collect and analyze applicable data relative to program process development targets. * You lead design control activities with emphasis on design transfer and a clear understanding of system design and the linkage between technical and business requirements, design and process failure modes and process controls. * You will review design changes and optimize manufacturing processes for new and existing medical devices, focusing on scalability, efficiency, and quality improvements. * You will utilize statistical tools and methods to analyze process data, conduct capability studies, and implement process controls. * You will help develop and execute test methods with necessary protocols and reports to validate process performance and product quality. * You will provide technical expertise in equipment selection, qualification, and validation, ensuring equipment meets performance and regulatory requirements. * You will collaborate cross-functionally with R&D, Quality Assurance, Regulatory Affairs, Supply Chain, Manufacturing to ensure seamless business strategy and transfer of technical deliverables in the quality management system. What makes you successful: * You have a degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or related field; Master's degree preferred. * Your proficiency is a strong technical understanding of experimental study design and measurement system analysis including the appropriate statistical approaches to data analysis. * You bring a robust understanding of medical device design transfer with knowledge of quality and regulatory standards. * You have experience in at least 1 of the following areas; Plastic component assembly, needles, adhesives, epoxies and curing, and packaging (sterile barrier, secondary, tertiary boxing) * You have an advanced communication skillset and can create and deliver concise status reports and presentations from the technical team up through executive leadership. * You bring an effective cross-functional collaboration experience amongst peers and leaders. * You have mentorship experience that allows you to guide junior engineers, fostering a culture of continuous learning and development within the team. What you'll get: * A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community. * A full and comprehensive benefits program. * Growth opportunities on a global scale. * Access to career development through in-house learning programs and/or qualified tuition reimbursement. * An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve. Travel Required: * 5-15% Experience and Education Requirements: * Typically requires a Bachelor's degree in a technical discipline, and a minimum of 8-12 years related experience or Master's degree and 5-7 years equivalent industry experience or a PhD and 2-4 years of experience. Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom's AAP may be viewed upon request by contacting Talent Acquisition at ****************************. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at ****************************. Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: ***************************************************** Code=MERITAIN_I&brand Code=MERITAINOVER/machine-readable-transparency-in-coverage?reporting EntityType=TPA_19874&lock=true To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications. Salary: $111,100.00 - $185,100.00
    $111.1k-185.1k yearly 52d ago
  • Staff Process Development Engineer

    Dexcom 4.7company rating

    San Diego, CA jobs

    The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Meet the team: You will be part of the Global Engineering team within Operations, tasked with end-to-end technical oversight of our manufacturing technologies spanning our suppliers, contract manufactures, automation houses, and internal manufacturing. Including providing technical support for on-market production at our manufacturing sites. You will bring your expertise and passion for the development, qualification, validation and change management of complex manufacturing automation equipment, working closely in cross-functional teams to integrate cutting-edge technology into our manufacturing processes. You will ensure high efficiency, precision, and quality in Operations. You will play a pivotal role in ensuring robust new product introduction, capacity expansion, and sustained on-market performance. This crucial role supports Dexcom's thrilling growth trajectory in delivering essential, life-changing products to our valued customers. As part of this dynamic and highly effective team, you will collaborate closely across multiple functions, gaining broad exposure to our entire product life cycle. Where you come in: You are a global engineering lead, managing execution of program deliverables that focus on both design/process changes to existing on Market product as well as new product development. Deliverables span from proof of concept to pilot manufacturing, to global high volume commercial automation. You will lead process development strategy, design of experiments and measurement system analyses to collect and analyze applicable data relative to program process development targets. You lead design control activities with emphasis on design transfer and a clear understanding of system design and the linkage between technical and business requirements, design and process failure modes and process controls. You will review design changes and optimize manufacturing processes for new and existing medical devices, focusing on scalability, efficiency, and quality improvements. You will utilize statistical tools and methods to analyze process data, conduct capability studies, and implement process controls. You will help develop and execute test methods with necessary protocols and reports to validate process performance and product quality. You will provide technical expertise in equipment selection, qualification, and validation, ensuring equipment meets performance and regulatory requirements. You will collaborate cross-functionally with R&D, Quality Assurance, Regulatory Affairs, Supply Chain, Manufacturing to ensure seamless business strategy and transfer of technical deliverables in the quality management system. What makes you successful: You have a degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or related field; Master's degree preferred. Your proficiency is a strong technical understanding of experimental study design and measurement system analysis including the appropriate statistical approaches to data analysis. You bring a robust understanding of medical device design transfer with knowledge of quality and regulatory standards. You have experience in at least 1 of the following areas; Plastic component assembly, needles, adhesives, epoxies and curing, and packaging (sterile barrier, secondary, tertiary boxing) You have an advanced communication skillset and can create and deliver concise status reports and presentations from the technical team up through executive leadership. You bring an effective cross-functional collaboration experience amongst peers and leaders. You have mentorship experience that allows you to guide junior engineers, fostering a culture of continuous learning and development within the team. What you'll get: A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community. A full and comprehensive benefits program. Growth opportunities on a global scale. Access to career development through in-house learning programs and/or qualified tuition reimbursement. An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve. Travel Required: 5-15% Experience and Education Requirements: Typically requires a Bachelor's degree in a technical discipline, and a minimum of 8-12 years related experience or Master's degree and 5-7 years equivalent industry experience or a PhD and 2-4 years of experience. Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom's AAP may be viewed upon request by contacting Talent Acquisition at ****************************. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at ****************************. Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: ***************************************************** Code=MERITAIN_I&brand Code=MERITAINOVER/machine-readable-transparency-in-coverage?reporting EntityType=TPA_19874&lock=true To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications. Salary: $111,100.00 - $185,100.00
    $111.1k-185.1k yearly Auto-Apply 52d ago
  • Principal Process Development Engineer

    Dexcom 4.7company rating

    San Diego, CA jobs

    The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Meet the team: You will be part of the Global Engineering team within Operations, a team that leads end‑to‑end technical oversight across external suppliers, contract manufacturers, and specialized automation partners for our wet chemistries, electronics, and hardware systems. You will play a lead role in translating novel materials, chemistries, and polymer systems into robust, scalable manufacturing solutions for new product introductions (NPI), on‑market changes, and sustained performance across the Dexcom portfolio. You will collaborate closely across R&D, Quality, Regulatory, Supply Chain, and Manufacturing, gaining broad exposure across the full product lifecycle from advance tech development through commercialization. Where you come in: You will support a range of programs from new product introductions and launches to scale up, on-market, and end of life management. Leading collaborative efforts and directing material selection activities, ensuring seamless progression, timely feedback, and optimization, while fostering teamwork and accountability. Anticipate and respond to changing market requirements by positioning the business to proactively address emerging regulatory and stainability trends and market shifts; maintained business continuity, customer satisfaction, and competitive margin profile/performance differentiation. Preparation Establish manufacturing readiness plans for chemical and polymer unit operations and associated in‑process controls, align process requirements, materials specifications, and analytical test strategies ahead of transfer. Define process performance targets and critical quality attributes and process parameters using first‑principles materials science and structured experimentation DOEs, supported by statistical methods. Manufacturing Transfer Lead technology transfer from R&D to Operations, including development of process flow maps and control strategies, coordinate equipment user requirement documents, with robust validation to meet cGMP/FDA/ISO requirements. Partner with Analytical Development/Quality to transfer and validate analytical and assay methods into QC environments, including robust test method development and validation. Drive materials selection and supplier process qualification ensuring material lots and supply chain are compatible with scale‑up and compliance requirements to support sustained, robust global manufacturing. Scale Architect scale‑up roadmaps from lab/pilot to high‑volume manufacturing, balancing process physics, materials behavior (structure‑processing‑property relationships), and production constraints. Implement data pipelines for capability monitoring and continuous improvement. Lead root‑cause investigations and failure analysis across material-process-product interactions. Then deploy corrective/preventive actions that harden process robustness and product reliability. Provide technical leadership to internal teams and external manufacturing partners. What makes you successful: Recognized subject matter expertise in chemical and polymer systems with demonstrated mastery of structure-processing-property relationships and their application to high volume, highly regulated medical device/diagnostics manufacturing. Proven leadership of technology transfer programs spanning process design, validation, and analytical method transfer; comfortable navigating device/diagnostic cGMP, FDA, and ISO environments. You have will have a track record of cross functional influence, from executive level communication to coaching engineers. Bring clarity in ambiguity and driving decisions that integrate business strategy with technical depth. You stay abreast of advancing technologies and processes, and the competitive landscape, proactively seeking out opportunities for implementation. You will closely engage with cross-functional partners in manufacturing, R&D, supply chain, and quality assurance. You drive innovation in approach, processes, and methodologies while ensuring adherence to company, customer, and industry requirements and specifications. This includes offering recommendations for technology and process solutions to enhance performance and achieve both short-term and long-term objectives. You engage in an environment of personal and team accountability, that is conducive the development and growth of the team through mentoring and coaching. Key Competencies: PhD or MS in Chemical Engineering, Materials/Polymer Science, Analytical Chemistry, Pharmaceutical Sciences, or related field (PhD Preferred). Diagnostics/pharma/biotech experience, especially in analytical development and method transfer supporting device/assay workflows. Demonstrated success in NPI and manufacturing scale‑up for chemical/polymer processes, including validation to cGMP and ISO standards; familiarity with combination product interfaces is a plus. Proficiency with Six Sigma/Lean, statistical tools, and manufacturing execution documentation (pFMEA, control plans, sampling plans). What you'll get: A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community. A full and comprehensive benefits program. Access to career development through in-house learning programs and/or qualified tuition reimbursement. An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve. Travel Required: 25 to 50% Experience and Education Requirements: Typically requires a Bachelor's degree in a technical discipline, and a minimum of 15+ years related experience or a Master's degree and 10+ years equivalent industry experience or a PhD and 7+ years of experience. Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom's AAP may be viewed upon request by contacting Talent Acquisition at ****************************. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at ****************************. Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: ***************************************************** Code=MERITAIN_I&brand Code=MERITAINOVER/machine-readable-transparency-in-coverage?reporting EntityType=TPA_19874&lock=true To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications. Salary: $164,200.00 - $273,600.00
    $87k-110k yearly est. Auto-Apply 8d ago
  • Standards Engineer (Civil) II | T&D

    Aps 4.1company rating

    Valle, AZ jobs

    Arizona Public Service generates reliable, affordable and clean energy for 2.7 million Arizonans. Our service territory stretches across the state, from the border town of Douglas to the vistas of the Grand Canyon, from the solar fields of Gila Bend to the ponderosa pines of Payson. As the state's largest and longest-serving energy provider, our more than 6,000 dedicated employees power our vision of creating a sustainable energy future for Arizona. Since our founding in 1886, APS has demonstrated a strong commitment to our customers in one of the country's fastest growing states, earning a reputation for customer satisfaction, shareholder value, operational excellence and business integrity. Our present and future success depends on the creative and dedicated people of our company who demonstrate the principles outlined in the APS Promise: Design for Tomorrow, Empower Each Other and Succeed Together. Summary We are seeking a skilled and motivated T&D Standards Engineer (Civil) II/III to support the safe, reliable, and efficient construction, operation, and maintenance of our Transmission & Distribution (T&D) systems. In this role, you will apply your civil engineering expertise to moderate-scale engineering and construction projects, contributing to the development and enhancement of T&D standards and practices. Key responsibilities include creating and maintaining construction standards and material specifications, conducting engineering analyses, evaluating materials and failed components, and supporting internal design and construction teams. You'll play an active role in identifying improvement opportunities across T&D design and construction processes, and will have increasing responsibility for technical decisions, guidance, and customer engagement. The ideal candidate is detail-oriented, collaborative, and proactive in staying informed on industry trends and emerging technologies. Occasional after-hours support may be required. Minimum Requirements Engineer II A four-year Bachelors degree in an engineering discipline or related applied science discipline (see approved list) from an ABET accredited institution, an International Engineering Alliance (IEA) recognized institution or an ABET Mutual Recognition Agreement (MRA) plus two (2) years working experience in Engineering-related positions. Engineer III A four-year Bachelors degree in an engineering discipline or related applied science discipline (see approved list) from an ABET accredited institution, an International Engineering Alliance (IEA) recognized institution or an ABET Mutual Recognition Agreement (MRA) plus five (5) years working experience in Engineering-related positions. Approved Engineering degrees: Materials Science/Metallurgy, Physics, Chemistry, Nuclear, Electrical, Mechanical, Civil, Electronics, Computer Science, Environmental, Chemical, Structural. (A four-year bachelor of Engineering Technology degree is not considered an automatic equivalent for a B.S. degree in Engineering. A review of the degree program curriculum must be completed by Engineering department management.) Preferred Special Skills, Knowledge or Qualifications: Civil/Structural Engineering Degree. Experience in structural loading analysis using O-Calc or other similar software programs. Ability to apply good construction, operating and engineering practices while adhering to the APS safety rules and company policies. Good oral and written communications skills. Major Accountabilities 1) Analyzes and prepares a variety of data, technical reviews and evaluations, trend analyses, short to long-range technology assessments, products and services, investigations, product/specification verifications to aid decision making. May present findings to a diverse group of management, internal staff, customers, vendors, etc. 2) Identifies, communicates and advocates resolution of technical concerns while adhering to sound engineering principles during evaluation / resolution of the conditions. Challenges conditions and decisions when needed to ensure T&D Standards, engineering designs, project controls and oversight of work has high technical quality, is cost effective, in compliance with established standards, codes and regulations, maintains future reliability, satisfies customer requirements, budget and schedules to meet or exceed all reasonable or agreed upon customer service levels. 3) Interfaces with customers or cross organizational team members to assess their needs, determine the scope of the project, obtain necessary data to make key decisions which may require consultation with external or internal customers or employees. 4) May provide oversight of engineering technical programs by managing the program requirements, working with cross organizational partners, reviewing and internalizing operating experience and coordinating corrective actions to ensure engineering program elements continue to meet T&D standards. 5) Provides support for projects and modifications that will increase operating efficiency. May review design and documentation of projects to ensure compliance with design specifications, schedules and any regulatory requirements. 6) Plans, coordinates, sets priorities, and applies resources on moderate projects or processes. 7) Takes initiative to eliminate barriers and uses resources to ensure desired results. 8) Checks and reviews standard analysis, evaluations, and investigations of others. 9) Provides technical guidance and leadership to less experienced engineers. 10) Remains cognizant of current technology and engineering developments as well as industry and competitive developments. 11) Maintains high individual level of engineering technical capabilities and expertise by formal education, self-study, and awareness of technology advances. Export Compliance / EEO Statement This position may require access to and/or use of information subject to control under the Department of Energy's Part 810 Regulations (10 CFR Part 810), the Export Administration Regulations (EAR) (15 CFR Parts 730 through 774), or the International Traffic in Arms Regulations (ITAR) (22 CFR Chapter I, Subchapter M Part 120) (collectively, 'U.S. Export Control Laws'). Therefore, some positions may require applicants to be a U.S. person, which is defined as a U.S. Citizen, a U.S. Lawful Permanent Resident (i.e. 'Green Card Holder'), a Political Asylee, or a Refugee under the U.S. Export Control Laws. All applicants will be required to confirm their U.S. person or non-US person status. All information collected in this regard will only be used to ensure compliance with U.S. Export Control Laws, and will be used in full compliance with all applicable laws prohibiting discrimination on the basis of national origin and other factors. For positions at Palo Verde Nuclear Generating Stations (PVNGS) all openings will require applicants to be a U.S. person. Pinnacle West Capital Corporation and its subsidiaries and affiliates ('Pinnacle West') maintain a continuing policy of nondiscrimination in employment. It is our policy to provide equal opportunity in all phases of the employment process and in compliance with applicable federal, state, and local laws and regulations. This policy of nondiscrimination shall include, but not be limited to, recruiting, hiring, promoting, compensating, reassigning, demoting, transferring, laying off, recalling, terminating employment, and training for all positions without regard to race, color, religion, disability, age, national origin, gender, gender identity, sexual orientation, marital status, protected veteran status, or any other classification or characteristic protected by law. For more information on applicable equal employment regulations, please refer to EEO is the Law poster. Federal law requires all employers to verify the identity and employment eligibility of every person hired to work in the United States, refer to E-Verify poster. View the employee rights and responsibilities under the Family and Medical Leave Act (FMLA). In compliance with the Drug Free Workplace Act of 1988, the Company is committed to a work environment that is free from the effects of alcohol and controlled substances, and free from the abuse or inappropriate use of prescribed and over-the-counter medications. The Company requires employees to be subject to drug and alcohol testing that is job-related and consistent with business necessity, regulatory requirements and applicable laws. Hybrid: Employees in hybrid roles work both in their home offices (virtually) and alongside their colleagues (in person). In order for employees to build strong relationships and to promote meaningful in-person interactions, hybrid employees are expected to work about 40% of their time in-person at an APS or other (non-home office) location. *Employees are expected to reside in Arizona (or New Mexico for Four Corners-based employees). *Working from a home office requires adequate technology and an appropriate ergonomic set up. *Role types are subject to change based on business need
    $75k-104k yearly est. 60d+ ago

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