Process Engineer II Job in San Jose, California US
Process Engineer II
Description Purpose Develop capable processes and ensure efficient and effective transfer of product into production. Key Responsibilities Assess process capabilities, prioritize process improvement opportunities, and innovate and implement process improvements on multiple and moderately complex processes. Apply Six Sigma tools, including DOE and statistical techniques, and technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation. Execute the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems. Prepare and present technical data and recommendations at technical reviews. Write protocols, execute and write reports for process validation and verification (OQ/PQ/ATMV). Ensure proper documentation is completed to meet quality systems requirements. (e.g., BOM?s, Routers, FMEA?s, etc.) Oversee development builds associated with the project using special work requests. Develop qualified production lines. Provide Design for Manufacturability (DFM) input to the engineering print package. Contribute ideas or generate Intellectual Property submissions. Train and/or provide work direction to technicians and may train manufacturing personnel when required as part of a validation. May serve as core team member or extended team member on new product projects. Quality System Requirements In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. Requirements: Typical minimum education/years experience: BS in Engineering/Technical field; 3-5 years of direct related experience. Advanced (Master) degree may be substituted for applicable experience. Medical device experience highly preferred. Ability to work effectively with all cross-functional groups. Excellent communication skills.