Senior Development Quality Engineer

1 day ago

St Paul, United States Abbott Laboratories Full time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Senior Development Quality Engineer

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

  • Career development with an international company where you can grow the career you dream of.

  • Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

  • An excellent retirement savings plan with high employer contribution

  • Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

  • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

  • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our St. Paul, MN location in the Structural Heart Team. Our products include prosthetic heart valves, occluder and devices for treatment of other structural heart defects.

As the Senior Development Quality Engineer, you’ll support sustainability of commercially released products. This position is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

What You’ll Work On

  • Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).

  • Lead on-time completion of Quality deliverables and business initiatives. 

  • Support the definition of objective, measurable, discrete, and verifiable customer requirements and product requirements.

  • Lead Risk Management activities including analyzing field data to support Failure Mode Effects Analysis and Hazard Analysis.

  • Support Test and Inspection Method development including Method Validation activities.

  • Support Design Verification and Design Validation planning and execution, including cross-functional root-cause analysis investigation and resolution activities.

  • Support manufacturing process development and qualification for design changes on Commercial products.

  • Support Supplier related changes for Commercial products.

  • Maintain high standards for Device History File (DHF) content completion, integrity, and regulatory / standards compliance; collaboratively identifying, communicating, and resolving gaps.

  • Support, review, and approve Document Change Order in a timely manner.

  • Lead, coach, and mentor junior engineers.

  • Be innovative, resourceful, and work with minimal direction. Have excellent organization, problem solving, communication, and team leadership skills. Work effectively with cross-functional teams.

  • Build strong collaborative partnerships with cross functional teams including Program Management, Research & Development, Regulatory Affairs, Supplier Quality, Manufacturing Quality, Manufacturing Engineering and Process Development to ensure cross functional customer needs are met without creating barriers to development cost, time, and scope.

  • Support regulatory audits as a Subject Matter Expert for Design Controls and other aspects of the quality system.

  • Support and ensure internal & external audit responses and on-time product re-certifications.

  • Writes and revises SOPs, controlled forms, and related documents to ensure best practices and maintain compliance.

  • Own Corrective Action/Preventive Action (CAPA) investigations.

  • Additional duties may be identified by functional management based on current project/business objectives.

  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

  • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Required Qualifications

  • Bachelor’s degree within an Engineering field or a closely related discipline.

  • 5-8+ years of medical device engineering experience and demonstrated use of Quality tools/methodologies.

Preferred Qualifications

  • Bachelor’s or advanced degree in Mechanical or Biomedical Engineering

  • Prior experience with Cardiovascular medical devices

  • Familiar with 21 CFR Part 820, ISO 13485, ISO 14971, EUMDR, and MDSAP.

  • Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization.

  • Ability to work in a highly matrixed and geographically diverse business environment.

  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

  • Ability to leverage and/or engage others to accomplish projects.

  • Multitasks, prioritizes, and meets deadlines in timely manner.

  • Strong organizational and follow-up skills, as well as attention to detail.

  • Ability to travel occasionally (

  • Senior Development Quality Engineer

    2 weeks ago

    St Paul, United States The Fountain Group Full time

    We are seeking an experienced Development Quality Engineer to join our Structural Heart team at our St. Paul, MN location. The individual in this position will support sustainability of commercially released products or new product development. This position is responsible for maintaining a strong collaborative partnership with cross-functional team members...

  • Development Quality Engineer

    2 weeks ago

    St. Paul, United States Collabera Full time

    Primary Responsibilities: Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member). Lead on-time completion of projects supporting quality and business initiatives. Support the definition of objective, measurable, discrete, and verifiable customer requirements,...

  • Senior Development Quality Engineer

    19 hours ago

    Saint Paul, Minnesota, United States Abbott Laboratories Full time

    About Abbott LaboratoriesAbbott Laboratories is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.Job Title: Senior Development Quality...

  • Senior Quality Engineer

    3 weeks ago

    Saint Paul, Minnesota, United States Innovize Full time

    Job DescriptionJob Summary: Innovize is seeking a highly skilled Senior Quality Engineer to join our team. As a Senior Quality Engineer, you will be responsible for driving a culture of quality and continuous improvement within the company by promoting adherence to the Quality System requirements across all departments.Key Responsibilities:Ensure customer,...

  • Development Quality Engineer(Medical device)

    2 weeks ago

    St Paul, United States Intellectt Inc Full time

    Role: Sr. Development Quality EngineerLocation: St. Paul, MN - 55117Required Qualifications:• Bachelor’s degree within an Engineering field or a closely related discipline.• 5-8+ years of Medical Device engineering experience and demonstrated use of Quality tools/methodologies – Development Quality experience highly preferred• Familiar with 21 CFR...

  • Senior Product Quality Engineer

    2 weeks ago

    Saint Paul, Minnesota, United States 3M Full time

    About the RoleWe are seeking a highly skilled Senior Product Quality Engineer to join our team at 3M. As a key member of our team, you will be responsible for ensuring the quality of our products and processes.Key ResponsibilitiesSupport the development of new products and processes to ensure they meet our quality standards.Lead and support Change Managed...

  • Senior Quality Assurance Engineer

    2 days ago

    St Louis, Missouri, United States STERIS Full time

    Job Title: Senior Quality EngineerSTERIS is seeking a highly skilled Senior Quality Engineer to join our team. As a Senior Quality Engineer, you will be responsible for managing processes, resolving product issues, and leading projects to maintain and improve product quality and the quality system in accordance with regulatory standards.Key...

  • Senior Quality Assurance Engineer

    2 days ago

    St. Petersburg, United States Unavailable Full time

    Job Title: Senior Program Quality EngineerWe are seeking a highly skilled and experienced Senior Program Quality Engineer to join our team at General Dynamics Ordnance and Tactical Systems (GD-OTS). As a key member of our quality team, you will be responsible for overseeing program quality requirements, identifying and mitigating program risks, and ensuring...

  • Senior Process Engineer

    2 weeks ago

    St Paul, United States Bell International Laboratories Full time

    Position OverviewThe Senior Process Engineer will be responsible for leading the development, optimization, and scale-up of manufacturing processes for personal care and Over-the-Counter (OTC) products, with a focus on sunscreens and skincare formulations. The role requires a strong technical background in chemical engineering, process design, and continuous...

  • Senior Quality Assurance Engineer

    15 hours ago

    St Louis, Missouri, United States PeakActivity Full time

    Job Title: Senior QA EngineerWe are seeking a highly skilled and experienced Senior Quality Assurance Engineer to join our team at PeakActivity.Job SummaryThe successful candidate will play a crucial role in ensuring the quality and reliability of our product through automated testing and code reviews. As a Senior QA Engineer, you will lead the quality...

  • Senior Quality Engineer

    3 weeks ago

    St. Louis, MO, USA, United States Watlow Full time

    Job Title: Senior Quality EngineerWatlow is seeking a highly skilled Senior Quality Engineer to join our team. As a Senior Quality Engineer, you will be responsible for ensuring the quality of our thermal products and systems, and for leading efforts to improve our quality management system and business processes.Key Responsibilities:Develop and execute...

  • Senior Quality Assurance Engineer

    2 weeks ago

    St Louis, Missouri, United States PeakActivity Full time

    Job Title: Senior QA EngineerWe are seeking a highly skilled and experienced Senior Quality Assurance Engineer to join our team at PeakActivity. As a key member of our quality assurance team, you will play a crucial role in ensuring the quality and reliability of our product through automated testing and code reviews.Key Responsibilities:Implement and...

  • Senior Quality Assurance Engineer

    2 weeks ago

    St Louis, Missouri, United States PeakActivity Full time

    Job Title: Senior QA EngineerWe are seeking a highly skilled and experienced Senior Quality Assurance Engineer to join our team at PeakActivity. As a key member of our quality assurance team, you will play a crucial role in ensuring the quality and reliability of our product through automated testing and code reviews.Key Responsibilities:Implement and...

  • Senior Product Development Engineer

    2 weeks ago

    Saint Paul, Minnesota, United States Solventum Full time

    Join Solventum's Infection Prevention TeamWe are seeking a highly skilled Senior Product Development Engineer to join our team and contribute to the design, development, and testing of state-of-the-art medical devices.About the RoleThis is an exciting opportunity to work on complex hardware systems and consumables, and to support design activities for both...

  • Senior Quality Assurance Engineer

    2 weeks ago

    St. Louis, MO, USA, United States PeakActivity Full time

    Job Title: Senior Quality Assurance EngineerWe are seeking a highly skilled and experienced Senior Quality Assurance Engineer to join our team at PeakActivity. As a Senior Quality Assurance Engineer, you will play a crucial role in ensuring the quality and reliability of our product through automated testing and code reviews.Responsibilities:Implement and...

  • Senior Quality Assurance Engineer

    2 weeks ago

    St. Petersburg, FL, USA, United States General Dynamics - Ordnance and Tactical Systems (FL,TX,VA, IL) Full time

    Job Title: Senior Quality Assurance EngineerWe are seeking a highly skilled Senior Quality Assurance Engineer to join our team at General Dynamics - Ordnance and Tactical Systems. As a key member of our quality team, you will be responsible for ensuring the highest quality standards are met in our products and processes.Key Responsibilities:Oversee program...

  • Senior Quality Assurance Engineer

    3 weeks ago

    St. Louis, MO, USA, United States PeakActivity Full time

    Job Title: Senior Quality Assurance EngineerWe are seeking a highly skilled and experienced Senior Quality Assurance Engineer to join our team at PeakActivity. As a Senior Quality Assurance Engineer, you will play a crucial role in ensuring the quality and reliability of our product through automated testing and code reviews.Key Responsibilities:Implement...

  • Senior Product Development Engineer

    17 hours ago

    Saint Paul, Minnesota, United States 3M Full time

    Job Title: Senior Product Engineer3M is seeking a highly skilled Senior Product Engineer to join our team. As a key member of our global R&D team, you will be responsible for developing and improving our product lines, collaborating with cross-functional teams, and driving innovation to meet customer needs.Key Responsibilities:Develop and execute product...

  • Senior Product Development Engineer

    3 weeks ago

    Saint Paul, Minnesota, United States Solventum Full time

    Job Description:Solventum is seeking a highly skilled Senior Product Development Engineer to join our Infection Prevention Team. As a key member of our product development team, you will be responsible for designing, developing, and testing state-of-the-art medical devices.Key Responsibilities:Develop component and product specifications, and produce formal...

  • Senior Quality Assurance Specialist

    2 days ago

    Saint Paul, Minnesota, United States HOYA Vision Care Full time

    Job Title: Senior Quality EngineerAt HOYA Vision Care, we are seeking a highly skilled Senior Quality Engineer to join our team in Ramsey, MN. As a Senior Quality Engineer, you will play a critical role in ensuring the quality and safety of our medical devices.Key Responsibilities:Develop and implement quality plans and procedures to ensure compliance with...