Job Title - Sr R/D Engineer - Exempt

Job Location - Plymouth, Minnesota

Duration: 12 Months

Job Description -

• 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

• 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