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Job description
What you will do:
As a Sr. Project Engineer you will provide engineering support for New Product Introduction (NPI) process development ensuring that all activities are completed and documented in accordance with Stryker procedures.
Additional responsibilities:
- Coordinate with partners/stakeholders 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.
Minimum Requirements:
- Bachelor’s degree (B.S.) in Mechanical or related engineering discipline
- 2+ years of work experience
Preferred 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 3485 regulated industry- highly preferred
- Good understanding of Design for Manufacturing (DFM), related statistical tools and validation/verification techniques.