• Principal Design Assurance Engineer

    Actalent (Minneapolis, MN)


    We are seeking an experienced and highly skilled Principal Design Assurance Engineer to join our team in the medical device industry. The ideal candidate will play a critical role in ensuring the design and development of medical devices meet the highest standards of quality and regulatory compliance.

     

    Skills

     

    Medical device, Design assurance, Iso 13485, Design control, Risk management, Design validation, Validation, Quality engineering

     

    Additional Skills & Qualifications

     

    - Requires a minimum of a Bachelor’s degree in a technical field or equivalent professional experience.

     

    - Should have 10 to 15 years of experience in medical device industry with 3 to 5 years experience in Quality.

     

    - Possess a deep understanding of ISO 13485, CE Marking, EN ISO 5840, EU MDR (formerly MDD), FDA Medical Device Regulation (MDR), and FDA requirements.

     

    - Extensive knowledge of manufacturing processes and practices relevant to the company’s products.

     

    - Proficient in Microsoft Office applications including Excel, Word, and Outlook, with effective communication abilities, both oral and written.

     

    - Must be capable of multitasking in a dynamic, fast-paced work environment.

     

    - Essential to work collaboratively across all organizational levels.

     

    - Strong leadership skills required to manage subordinates, projects, and workflow effectively.

     

    - Exhibits exceptional organizational skills and the ability to prioritize multiple tasks.

     

    - Handles confidential and sensitive information with the utmost professionalism.

     

    - Detail-oriented with the flexibility to adapt to the company’s evolving needs.

     

    - Knowledgeable in statistics, data collection, analysis, and presentation techniques.

     

    - Excellent interpersonal, communication, and problem-solving skills.

     

    - Capable of working autonomously with minimal supervision, proactively seeking guidance when necessary.

     

    - Skilled in defining, organizing, and managing both individual and team tasks.

    Pay and Benefits

    The pay range for this position is $150000.00 - $170000.00/yr.

     

    4C Benefit Package for full time / exempt workers

     

    Workplace Type

     

    This is a fully onsite position in Minneapolis,MN.

     

    Application Deadline

     

    This position is anticipated to close on May 14, 2025.

    About Actalent

    Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

     

    The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

     

    If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.