Jobs
>
Minneapolis

    Design Assurance Engineer II - Minneapolis, United States - Abbott Laboratories company

    Abbott Laboratories company
    Abbott Laboratories company Minneapolis, United States

    1 week ago

    Default job background
    Description

    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.

    Design Assurance Engineer II

    About Abbott

    Abbott is a global healthcare leader, creating breakthrough science to improve peoples health. Were always looking towards the future, anticipating changes in medical science and technology.

    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. Youll 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 bachelors 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 Plymouth, MN location in the Electrophysiology business. In Abbotts Electrophysiology (EP) business, were advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

    As the Design Assurance Engineer II, youll represent Design Assurance on electrophysiology catheter and disposable sustaining engineering projects. This role is responsible for maintaining a strong collaborative partnership with cross-functional engineering teams to ensure that devices are developed and maintained in accordance with product requirements, and that they meet their intended use delivering the safest experience possible to our patients. This role will review requirements, specifications, and technical design documents to provide timely feedback aimed at improving product quality, safety, reliability, and manufacturability to sustaining engineering teams.

    What Youll Work On

    • Execute on Holistic & Strategic Design Verification/Validation Strategies with emphasis on
    • Technical analysis of requirements, specifications, and control strategy
    • Efficient and cost-effective execution of validation and verification
    • Maintain DHF, design input / design output, external requirements, and risk management documentation.
    • Lead risk management meetings assessing the impact of product or supplier changes to risk profile.
    • Execute design verification and validation activities including test planning and execution, and creation of protocols and reports.
    • Interpret external standards and implement product requirements and testing to meet external standards.
    • Ensure DHF content completion, integrity, and regulatory and standards compliance; collaboratively communicating and resolving gaps.
    • Support design, test, inspection method development, and lead method validation activities
    • Participate in root cause investigations, including corrective and preventive action activities, with the purpose of identifying the underlying issues and offering efficient long-term solutions.
    • Present to the manager level on significant matters
    • Serve as a back-room representative during internal and external inspections and inquiries from regulators such as FDA and ISO as it relates to design assurance.
    • Ability to work both within a team, and independently, in a geographically diverse business environment.
    • Strong verbal and written communications with effective communication at multiple levels in the organization
    • Perform other duties and responsibilities as assigned by functional management based on the current project/business objectives including 10% travel, including international travel and regular predictable attendance.

    Required Qualifications

    • Bachelor level degree in an Engineering or Science.
    • 1.5+ years experience.
    • Strong technical writing skills.
    • Experience with root cause identification and problem solving.

    Preferred Qualifications

    • Degree in Material Science, Mechanical, Biomedical, Electrical, or Chemical Engineering.
    • Engineering experience and demonstrated use of Quality tools/methodologies.
    • Knowledge of FDA, GMP, ISO 13485, and ISO
    • Prior medical device experience.

    Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

    Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:

    Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

    Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

    The base pay for this position is $57,300.00 $114, In specific locations, the pay range may vary from the range posted.

  • Carrier

    Design Assurance Engineer

    1 week ago

    Carrier Minneapolis, United States Full time

    About this role · The Product Design Assurance Engineer ensures product design quality and robustness trough the difference phases of a product development process. The Design Assurance Engineer is support the Engineering team in following internal or external process and guideli ...

  • General Dynamics

    Information Assurance Engineer

    1 week ago

    General Dynamics Minneapolis, United States

    Responsibilities for this Position · Information Assurance Engineer · ID: · USA-MN-Bloomington · Required Clearance: Secret · Posted Date: 2/6/2024 · Category: Security · Employment Type: Full Time · Hiring Company: General Dynamics Mission Systems, Inc. · Basic Qua ...

  • General Dynamics Corporation

    Information Assurance Engineer

    5 days ago

    General Dynamics Corporation Minneapolis, United States

    Responsibilities for this Position · Information Assurance Engineer · ID: · USA-MN-Bloomington · Required Clearance: · Secret · Posted Date: · 2/6/2024 · Category: · Security · Employment Type: · Full Time · Hiring Company: · General Dynamics Mission Systems, Inc. · Basic Qualifi ...

  • Cypress HCM

    Senior Design Assurance Engineer

    2 weeks ago

    Cypress HCM Minneapolis, United States

    This Quality Design Assurance Engineer role will focus on design assurance supporting product and process development to ensure a successful production launch and delivery of the highest quality product to the customer. This position also supports design change and other quality ...

  • Accordance Search Group

    Principal Design Assurance Engineer

    1 week ago

    Accordance Search Group Plymouth, United States

    Our client is an exciting medical technology company searching for a Principal Design Assurance Engineer. In this role you will lead design assurance activities and initiatives supporting Product Development projects including establishing and improving product design requirement ...

  • TLC Millimeter Wave Products, Inc.

    Senior Quality Assurance Engineer

    3 days ago

    TLC Millimeter Wave Products, Inc. Minneapolis, United States

    Job Description · Job DescriptionBenefits:401(k) · 401(k) matching · Competitive salary · Dental insurance · Free food & snacks · Health insurance · Paid time off · Parental leave · Vision insurance · Wellness resources · Job Title: Senior Quality Assurance Engineer · Department: ...

  • Padagis LLC

    Senior Engineer, Quality Assurance

    6 days ago

    Padagis LLC Minneapolis, United States

    Padagis LLC is seeking a Senior/Lead Quality Assurance Engineer to provide primary Quality Assurance review and approval for annual product reviews, deviations, and other cGMP documentation and studies conducted at PMN, ensuring that all information and documentation conforms to ...

  • NONIN MEDICAL INC

    Senior Design Assurance Engineer

    6 days ago

    NONIN MEDICAL INC Minneapolis, United States

    Job Description · Job DescriptionYou can count on Nonin. Our vision is to improve people's lives by creating noninvasive medical devices people can count on. Nonin's culture is grounded in our mission, and we live by our cultural tenets of courage, ownership, and agility. The cou ...

  • Resolution Medical

    Sr. Design Assurance Engineer

    2 days ago

    Resolution Medical Minneapolis, United States

    Job Type · Full-time · Description · Job Summary: · The Senior Design Assurance Engineer is a quality engineer that directly supports medical device product development from concept through commercialization working with cross-functional development teams to establish and main ...

  • Padagis LLC

    Senior Engineer, Quality Assurance

    2 weeks ago

    Padagis LLC Minneapolis, United States

    Padagis LLC is seeking a Senior/Lead Quality Assurance Engineer to provide primary Quality Assurance review and approval for annual product reviews, deviations, and other cGMP documentation and studies conducted at PMN, ensuring that all information and documentation conforms to ...

  • Abbott

    Design Assurance Engineer II

    1 week ago

    Abbott Minneapolis, United States

    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 medic ...

  • Veranex

    Senior Design Assurance Engineer

    2 weeks ago

    Veranex Minneapolis, United States

    Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data manag ...

  • Nonin Medical

    Senior Design Assurance Engineer

    2 days ago

    Nonin Medical Minneapolis, United States

    You can count on Nonin. Our vision is to improve people's lives by creating noninvasive medical devices people can count on. Nonin's culture is grounded in our mission, and we live by our cultural tenets of courage, ownership, and agility. The courage to challenge assumptions and ...

  • Abbott Laboratories

    Design Assurance Engineer II

    1 week ago

    Abbott Laboratories Minneapolis, United States

    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 medic ...

  • Money Fit by DRS

    Senior Engineer Quality Assurance

    2 weeks ago

    Money Fit by DRS Minneapolis, United States

    Padagis LLC is seeking a Senior/Lead Quality Assurance Engineer to provide primary Quality Assurance review and approval for annual product reviews, deviations, and other cGMP documentation and studies conducted at PMN, ensuring that all information and documentation conforms to ...

  • Philips Iberica SAU

    Principal Software Design Assurance Engineer

    4 weeks ago

    Philips Iberica SAU Minneapolis, United States

    Job Title Principal Software Design Assurance Engineer Job Description · Principal Software Design Assurance Engineer (Plymouth, MN hybrid) · The Principal Software Design Assurance Engineer will support the development, qualification, and commercialization of innovative, highly ...

  • Philips

    Principal Software Design Assurance Engineer

    2 weeks ago

    Philips Minneapolis, United States

    Principal Software Design Assurance Engineer (Plymouth, MN hybrid) · The Principal Software Design Assurance Engineer will support the development, qualification, and commercialization of innovative, highly reliable, life changing medical devices and associated software. · Your ...

  • Philips

    Principal Software Design Assurance Engineer

    4 weeks ago

    Philips Minneapolis, United States

    Principal Software Design Assurance Engineer (Plymouth, MN hybrid) · The Principal Software Design Assurance Engineer will support the development, qualification, and commercialization of innovative, highly reliable, life changing medical devices and associated software. · Your ...

  • Cypress HCM

    Senior Design Assurance Engineer

    3 weeks ago

    Cypress HCM Minneapolis, United States

    This Quality Engineer role will focus on design assurance supporting product and process development to ensure a successful production launch and delivery of the highest quality product to the customer. This position also supports design change and other quality initiatives. This ...

  • Olympus

    Engineer, Principal Quality Assurance

    2 weeks ago

    Olympus Minneapolis, MN, United States

    Working Location: MINNESOTA, BROOKLYN PARKWorkplace Flexibility: HybridAre you looking for a company that cares about people's lives and health, including yours? Let's inspire healthier lives, together.Olympus, a leading medical technology company, has focused on making people's ...