Senior Process Development Engineer (MedTech)

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

Benefits offered by this job

Health benefits

401(k) plan

Employee Stock Purchase Plan (ESPP)

Wellbeing program

Tobacco cessation program

Life and AD&D insurance

Short-term disability

Job summary

Stryker is seeking a Senior Engineer, Process Development for its OrthoTech Division. This is an onsite role in Portage, MI, focused on enabling new product introductions through rigorous process validation, testing, and documentation aligned with GMP and company procedures.

The candidate will lead capital projects, perform capability studies, and collaborate with Quality to ensure robust manufacturing processes while guiding manufacturing teams and maintaining compliance with industry standards.

Qualifications

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

Responsibilities

• Provide engineering support for new product and process introductions, ensuring documentation complies with NPD procedures.
• Ensure quality of process and product per specifications.
• Select components and equipment based on specs, reliability and regulatory requirements; develop testing protocols.
• Lead capital acquisition activities including equipment specification, negotiation, installation and validation.
• Analyze equipment to establish operating data and perform tests and analyses.
• Participate in Process FMEA, Control Plans, SOPs and PPAP generation for transfers and launches.
• Complete capability studies for in-process inspection and generate documentation.
• Conduct MSA studies for new products and processes.
• Provide training for manufacturing team members.
• Ensure adherence to GMP and safety procedures.
• Review and approve validation documentation.

Skills

Analytical skills

PFMEA

GD&T

CAD

Education

Bachelor's degree in engineering

Tools

CAD

Job description

Stryker is seeking a Senior Engineer, Process Development for its OrthoTech Division. This is an onsite role in Portage, MI, focused on enabling new product introductions through rigorous process validation, testing, and documentation aligned with GMP and company procedures.

The candidate will lead capital projects, perform capability studies, and collaborate with Quality to ensure robust manufacturing processes while guiding manufacturing teams and maintaining compliance with industry standards.