Staff Engineer, Advanced Operations

This position is responsible for process design, development, and validation while collaborating with diverse, cross-functional teams throughout new product development. The role involves independently identifying solutions and developing approaches to technical challenges of moderate scope and complexity. The individual will apply modern engineering methodologies to help accelerate time-to-market while meeting regulatory requirements, project timelines, and cost targets. They will cultivate effective working relationships both internally and externally, and may also provide occasional guidance and training to other team members.

What you will do:

• 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.
• 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.
• 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.
• Provide 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).
• 4+ 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.