Description
SUMMARY Results-oriented Engineering Professional, with extensive experience designing and delivering medical, bio-medical, and scientific diagnostic instrumentation to achieve overall business objectives. A clear communicator, that is flexible and adaptable, with the ability to work effectively across organizational lines to deliver projects on schedule. A seasoned engineer and project manager, with the expertise to develop a product from the initial voice of the customer phase, through to production launch. * Product Dev., N.P.I. & Sustaining Engineering & Project Management Production Level Documentation 510K Submission/Regulatory Testing FDA, 13485, 21CFR, GMP, ISO DFM, DFT, and Design Improvement Design Validation & Verification Risk Analysis & Mitigation Formal Design Presentations and Reviews CAD- Solid Works, Pro-Engineer
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