Work Flexibility: Hybrid

What you will do: Key responsibilities: Coordinate with partners/end users to deliver value to business through opportunity identification, execution, and solution delivery. Ensure quality of process and product as defined in the appropriate operation and material specifications. Will select components and equipment based on analysis of specifications, reliability, and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols. May lead/support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation. Will analyze equipment to establish operating data, conduct experimental test and result analysis. Lead and/or participate in process review meetings. Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product launches. Complete capability studies for in process inspection and generate subsequent Inspection documentation. Conduct MSA studies for new products and new processes. Provide training for manufacturing team members. Ensure adherence to GMP and safety procedures. Review and approval of validation documentation. Who we want: Minimum Requirements: Bachelor’s degree (B.E.) in Mechanical or related engineering discipline required. 5+ years of work experience required Analytical problem solversDedicated achieversCollaborative partnersPreferred Qualifications: Good knowledge of manufacturing processes, materials, product, and process design Project Management experience Ability to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing. Experience in an FDA regulated or ISO 13485 regulated industry- highly preferred. Good understanding of Design for Manufacturing (DFM) related statistical tools and validation/verification technique

Travel Percentage: None