Senior Process Engineer, Advanced Operations

Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Senior Engineer, Process Development to join our OrthoTech Division. This is an onsite position in Portage, MI.

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. Work with quality engineers to develop component specific testing and inspection protocols.

• 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 Process Failure Mode and Effect Analysis, Control Plan, SOP and Production Part Approval Process generation associated with product transfers and 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.

What you need:

• Bachelor’s degree in engineering required

• 2+ years of applicable full-time work experience required

• Working knowledge of PFMEA required

• Excellent analytical skills, ability to plan, organize, and implement concurrent tasks required

• Good knowledge of manufacturing processes, materials, product and process design required

• Ability to read and interpret complex engineering drawings and understand geometrical dimensioning and tolerancing (GD&T) required

• CAD experience

$77,700 - $129,500 USD Annual