Strong skills in relevant modeling, design controls and/or statistical analysis.
Experience in Strutured Product Development using Design Controls in a Medical Device/Combination Product Development industry. Experience in working with technical requirements, Design Verification testing, protocols and reports writing.
Strong Design Skills (i.e. Tolerance Stackup Analysis, Test Method Validation/Gage R&R and Fixture Development, Development of Drawngs and Specifications)
Write and execute Design Verification protocols and reports, including integrating the use of appropriate statistical tools in validation protocols, and applying training materials for test methods.
CAD (Solidworks/Creo), Rapid prototyping, GD&T, Design for Manufacturability, Injection Molding.
Full data and statistical analysis (JMP, Minitab) and Design of Experiments.
Design Controls for regulatory compliance & filing (ISO 13485, etc): GDP/GLP/GMP, Design History Files, protocols/reports, hazards analyses, batch records, etc.
Six Sigma (Green/Black Belt): DMAIC and DFSS.
Excellent communication skills are required. Experience in working with external partners is also highly desirable.
Highly organized and detail oriented.
Excellent leadership skills.
B.S, M.S, Ph.D or advanced degree in Engineering, with preferences for Mechanical Engineering or equivalent.
At least 8 years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelors degree.
Experience in the Medical Device industry is expected
Travel: 2-3 Days a month to Minnesota (a must)