Senior Process Engineer, Medical Devices Development

Stryker Corporation; Portage (MI); On-site; USD 78,000 - 130,000; Full time

Job summary

Stryker Corporation in Portage, MI is seeking a Senior Engineer, Process Development to lead new product and process introductions on an onsite basis. You will ensure process and product quality, select components and equipment, and collaborate with QA to develop testing protocols.

The role requires a bachelor’s degree in engineering, 2+ years experience, PFMEA and GD&T proficiency, CAD skills, and the ability to read complex drawings.

Qualifications

• Bachelor’s degree in engineering required.
• 2+ years of applicable full-time work experience required.
• Working knowledge of PFMEA required.
• Ability to read and interpret complex engineering drawings and GD&T required.
• CAD experience required.

Responsibilities

• 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.

Skills

Analytical skills

Planning & organizing

Reading drawings

GD&T knowledge

Education

Bachelor’s degree in engineering

Tools

PFMEA

CAD

Job description

Stryker Corporation in Portage, MI is seeking a Senior Engineer, Process Development to lead new product and process introductions on an onsite basis. You will ensure process and product quality, select components and equipment, and collaborate with QA to develop testing protocols.

The role requires a bachelor’s degree in engineering, 2+ years experience, PFMEA and GD&T proficiency, CAD skills, and the ability to read complex drawings.