Mechanical Engineering Experience: 14+ yearsProject Engineering Experience: 12 yearsSolidworks Experience: 7+ yearsMedical Device Experience: 8+ yearsElectro-Mechanical Design Experience: 7 yearsIndustries Served: medical device (FDA, ISO 13485), automotive (PPAP, 6sigma), consumer electronics, mobile phone accessories, industrial machinery, oilfield.Part/Material Design: plastic injection, rubber (LSR, compression, over-molding), adhesives, electronics assembly design, assembly sealing (IPX7), metal (CNC machining, anodization, grinding, casting, die-forming), secondary processes (painting, silkscreening, laser etching).Medical Device Experience: lead projects within a regulated environment. Complete Design History Files (per 21CFR820.30 and ISO 13485). Manage production validation (IQ, OQ, PQ). Perform risk management (DFMEA and PFMEA per ISO 14971). Have participated in customer and ISO 13485 audits. Day-To-Day Skills: typically work on the project from feasibility assessment, to concept, to CAD, to 3D model simulations (FEA), to prototyping, to testing, to vendor vetting, manufacturing tooling-up, production validation, quality control and finaly shipping of a finished product. Project Management: Apply project management tools to schedule project milestones, assign tasks and tabulate project risk. Report to director of engineering, VP of sales and president on progress of project. Manage interns and engineers to complete engineering tasks. Work with cross functional teammates from manufacturing, sales, purchasing and quality to complete project. Organizational Skills: thorough. See nice neat list above as example.
Listed skills include Manufacturing, Product Development, Project Management, Design For Manufacturing, and 25 others.