Sr R/D Engineer
2300 Berkshire Lane North Plymouth, MN 55441 US
Job Description
Can you please confirm your top 3 skills sets required?
-
- Phase 2 & Phase 3 test development and testing. Â
- characterization protocol generation and testing
- design verification protocol generation and testing
- test method development and validationÂ
- fixture development
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- Review and analyze current testing and confirm if additional testing is needed.Â
- Generate testing data to support testing strategy.Â
- develop and validate test methods used to generate test data.Â
- Possible:Â Review of technical specifications and requirement documents
- Possible:Â Modify current design to align to newer product technology/requirements
- Possible:Â Translate new requirements to supplier
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.Â
- 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.Â
- Completes tasks associated with area of responsibility within assigned schedule.Â
- Solid understanding of regulatory indications and requirements, such as IDE, 510k, PMA’s, contributes to assigned sections of submission documents.
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 -Â 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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