Staff Engineer, Advanced Operations

• Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker new product development procedures.
• 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.
• 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 transfers and launches.
• Complete capability studies for in process inspection and generate subsequent Inspection documentation.   
• Provides on-going status reports including periodic reviews progress and evaluation of results to management.
• 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.
• Must be able to generate, follow and explain detailed proposals and operating procedures (i.e. assembly instructions, inspection procedures, and capital project proposals).
• Must be able to analyze and correct complex product and/or process issues using independent judgement.
• Must be able to routinely make decisions that affect immediate operations.
• Must be able to plan, organize, and implement multiple concurrent tasks.

What you need:

• Bachelor’s Degree in Engineering (Mechanical, Biomedical, Electrical Engineering preferred).
• Project management experience preferred.
• 5+ years related years of experience.
• Experience in executing complex problem-solving techniques related to manufacturing/design technical issues. Good instincts and sound judgement for mechanical and structural design.
• Good understanding of Design for Manufacturing (DFM), related statistical tools and validation/verification techniques.
• Good knowledge of manufacturing processes, materials, product and process design.
• Must be able to read and interpret complex engineering drawings and have a good understanding of geometrical dimensioning and tolerancing.
• Experience in an FDA regulated or regulated industry preferred.

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