Staff Engineer, Advanced Operations, Portage, MI

Stryker is hiring a Staff Engineer, Advanced Operations who will be responsible for process design, development, and validation while collaborating with diverse, cross-functional teams throughout new product development. This 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. This is a hybrid position in Portage, MI.

What you will do:

• Provide engineering support to design and implement processes for new product development including capital equipment acquisition, fixture design and development, process capability studies, validation, documentation and training.
• Ensure quality of process and product as defined in the appropriate operation and material specifications.
• 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.
• Conduct MSA studies for new products and new processes.
• Provide on-going status reports including periodic reviews progress and evaluation of results to management.
• Provide training for manufacturing team members.
• Ensure adherence to GMP and safety procedures.
• 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).
• 5+ years related years of experience in new product development and/or complex manufacturing.
• 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.

$89,300 - $148,800 USD Annual