Jobs
>
Minneapolis

    Senior Design Assurance Engineer - Minneapolis, United States - Veranex

    Veranex
    Veranex Minneapolis, United States

    2 weeks ago

    Default job background
    Description
    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 management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment.

    At every stage, Veranex clients realize efficiencies in cost and time, while our comprehensive solutions unify the entire development process.

    Veranex partners with the world's most influential life science and medical device companies to research, design, develop and commercialize new healthcare technologies and treatments to advance patient care.


    About This Role:
    Veranex has an exciting opportunity to join our team as a Senior Design Assurance Engineer. You will be part of a team working to improve lives globally through medical technology innovation.

    The Senior Design Assurance Engineer is responsible for accurate, independent generation and evaluation of risk management, design history file documentation and overall quality system compliance.

    Ensures compliance to customer and regulatory requirements and assists with the successful transfer of design to manufacturing. Plans and leads execution of risk management on cross-functional product development teams.


    What You Will Do:
    Creates, manages and/or executes test objectives, test plans and schedules.

    Coordinates test resources for engineering and design verificationConducts risk management for novel and existing medical devices, including risk management plans and reports, hazard analyses and use, design, and process Failure Mode & Effects Analysis (FMEA).Assists with implementing and maintaining a quality system that is compliant with relevant quality system regulation requirements.

    Provides input to development teams in the design of highly complex medical devices (includes electrical, mechanical, software, drug, IVD). Provides quality insight and leadership on program teams and assists with establishing appropriate build quality controls appropriate with use.
    Ensures the successful integration of quality assurance and regulatory compliance, working across multiple teams and medical device/equipment categories.
    Develops, documents, and validates inspection and test methods to support development and manufacturing.

    Supports internal and external audit activitiesParticipates in design reviewsTrains and mentors new and less experienced engineersQualifications:


    Required skills:


    Bachelor's or Master's degree in quality, engineering or related field4-6 years of relevant work experience in medical devices, or an equivalent combination of education, experience and trainingExpert in ISO13483 and ISO14971.

    Has experience in ISO10993, IEC60601, IEC62304, IEC62366, MDR and IVDR.

    Strong understanding of Food & Drug Administration (FDA) Quality System regulations, European Active Implantable & Medical Device Regulations, and relevant medical device principlesExcellent written and oral communication skillsExcellent attention to detailPreferred:


    Demonstrated experience with client managementExperience with different quality management systemsVeranex is an equal opportunity employer and prohibits discrimination of any kind.

    All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.

    Other details

    Job Family Design AssuranceJob Function Design AssurancePay Type SalaryEmployment Indicator Regular

    Apply Now
    #J-18808-Ljbffr
  • 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 ...

  • 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 ...

  • 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 ...

  • 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 ...

  • Abbott Laboratories company

    Design Assurance Engineer II

    1 week ago

    Abbott Laboratories company 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 ...

  • 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 ...

  • 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 ...

  • 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 ...

  • 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

    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 ...

  • 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 ...

  • 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 ...