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Sr R/D Engineer

Plymouth, MN 55441

Posted: 02/05/2025 Employment Type: Contract Job Category: Engineering Job Number: 617225 Is job remote?: No Country: United States

Job Description


Can you please confirm your top 3 skills sets required?
  1. Phase 2 & Phase 3 test development and testing.  
  2. characterization protocol generation and testing
  3. design verification protocol generation and testing
  4. test method development and validation 
  5. fixture development
  • Analysis of technical specifications and requirements. 
  • Design modification – translations into/ to specifications/requirements
  • Testing/qualification of new components Can you please confirm the 3 main responsibilities/day to day activities required for this role?
    1. Review and analyze current testing and confirm if additional testing is needed. 
    2. Generate testing data to support testing strategy. 
    3. develop and validate test methods used to generate test data. 
    4. Possible:  Review of technical specifications and requirement documents
    5. Possible:  Modify current design to align to newer product technology/requirements
    6. Possible:  Translate new requirements to supplier
    What products (if any) will this role support?  This will be supporting our NPD program PELE while possibly being a resource on other initiatives. 

    What is your target years of experience?  8-10 years - need someone that is independent and has enough experience



    Responsibilities may include the following and other duties may be assigned.
    • Understands the requirements of cross-functional internal customers.
    • Understanding and wide application of technical principles, theories and concepts in the field.
    • Participates in preclinical evaluations.
    • Responsible for subset of product design. 
    • Develops product specs, test methods, equipment. Execute tolerance analysis.
    • Creates, reviews and approves protocols/reports.
    • Interprets test results.
    • Working knowledge of DRM and statistics.
    • Responsible for subsystems of designs or smaller designs in their entirety. 
    • Completes tasks associated with area of responsibility within assigned schedule. 
    • Solid understanding of regulatory indications and requirements, such as IDE, 510k, PMA’s, contributes to assigned sections of submission documents.
    Working knowledge of internal quality system (e.g. SOPs, DOPs), external quality standards, and statistical methods.
    Design characterization and design selection experience


    Nice to Have (Preferred Qualifications)
    • Experience with medical device-based products, processes, and technologies
    • Medical Device/Pharmaceutical or other regulated industry experience
    • Design characterization and design selection experience
    • Experience with SolidWorks or AutoCAD
    • Proven experience executing product changes regulated by design control, applying product development process to derivative product line
    • Mechanical design experience -  modeling for devices and fixtures
    • Prototyping of devices and fixtures through 3d printing and/or machining; catheter device experience
    • Device design verification testing and test development
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    About Plymouth, MN

    Ready to take the next step in your career? Explore job opportunities in the vibrant Plymouth, Minnesota area! Known for its picturesque parks, including the popular French Regional Park and the stunning golf course at Rush Creek, Plymouth offers a perfect blend of urban convenience and natural beauty. Home to iconic landmarks like Minnetonka Theatre and Eddington House, this bustling city boasts a rich arts scene and a thriving culinary landscape. Cheer on the local sports heroes at the nearby Target Center or take a leisurely stroll through the charming shops at The Shoppes at Arbor Lakes. With a plethora of opportunities for professional growth and a welcoming community atmosphere, Plymouth is the ideal place to grow your career. Browse our job listings today and discover your next adventure in this amazing city!

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