Sr Engineer II, Process

Job description

Job Summary: The Sr. Engineer II, Process is responsible for developing, improving, and validating new and existing manufacturing processes, equipment, tooling, and fixtures. This position leads and/or supports new process development (NPI) and product transfers to worldwide manufacturing facilities, implements and supports/utilizes effective manufacturing methodologies, such as Lean manufacturing, DFM, visual Workshop, SPC, etc., always following local and international regulatory standards (e.g. 21 CFR, Part 820 and ISO 13485:2003). Duties & Responsibilities: - Assist in setting up World Class Manufacturing capability for the Company’s products. - Responsible for the design/specification/purchase/installation/qualification of the Company’s manual/ automated assembly equipment and tooling. - Work closely with design engineering to proactively influence designs for better manufacturability. - Develop manufacturing plans, project timelines, requirements, specifications, and process flow. - Generate Manufacturing Assembly and In-Process Acceptance Procedures and train production personnel. - Develop the Validation Master Plans and perform process validations (IQ, OQ, PQ), including g...