| Overview Lead design transfer out of R&D. Develop, implement and improve manufacturing capabilities. Assist Manufacturing capabilities in productivity, product quality and cost through the development and implementation of novel and effective methods, tools, equipment, and processes. Contribute to product design improvements intended to achieve higher reliability, serviceability, and manufacturability. Train technicians and manufacturing personnel on manufacturing equipment operation, procedures and inspections . |
| Principal Responsibilities • Provide best-practice leadership within product development staff to ensure that products under development are optimally manufacturable that may include but not be limited to mechanical assembly/dimensioning/tolerances, electrical wiring, materials selection and fabrication methods. • Design and develop manufacturing processes for new products, product changes and enhancements, and related tooling and fixtures which are consistent with a zero-defect level as well as low product cost. • Perform Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), and DOEs. • Create and maintain accurate documentation of concepts, designs concepts, tool drawings and shop orders in coordination with the Quality Assurance and R&D functions. • Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations |
| Training, Skills, Knowledge and/or Experience Requires a minimum of 10-15 years’ related experience. • Demonstrated experience with complex electro-mechanical and/or opto-mechanical products and manufacturing processes is required, low to medium volume is preferred • Demonstrated experience with disposable or single-use devices is preferred • Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. • Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. • May determine methods and procedures on new assignments and may provide guidance to other lower-level personnel. Must be competent with Word, Excel, Project, Power Point applications. Experience with Design of Experiments and statistical analysis packages. |
| Education Requirements Requires a Bachelor/Master’s degree (or equivalent) in engineering or related discipline Six Sigma, Black Belt Certification is a strong plus |
| Supervisory Responsibility Lead a small team of Manufacturing Engineers |
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