Product Transfer Engineer - Change Control & Improvement

Stryker Corporation; Hinoba-an; Hybrid; Confidential; Full time

Job summary

Stryker Corporation is seeking a qualified professional to support the SICR process, implement improvements, and maintain the electronic systems in OnePLM. The role requires collaboration with global suppliers and cross-functional teams to ensure timely change execution.

The candidate should have a strong background in manufacturing, GMP/ISO standards, and experience with PPAP, MSA, and PFMEA. Travel up to 10% may be required.

Qualifications

• Honors Bachelor's degree in Engineering or Science.
• 3+ years of experience in manufacturing environment or equivalent.
• Knowledge of GMP, ISO 13485, 21 CFR Part 820.
• Strong communication skills.
• Willing to travel to different locations.
• Experience with PPAP, MSA, SPC documentation.
• IQ/OQ/PQ validations.
• Understanding of welding, molding, machining processes.
• Experience with PFMEA & Control Plan.

Responsibilities

• Support SICR process improvements and maintain electronic systems.
• Own and execute Supplier Initiated Change Requests (SICRs) and coordinate with Global Suppliers.
• Review SICRs for completeness; challenge suppliers for missing information.
• Organize SCRB with stakeholders and secure buy-in for changes.
• Execute ECR/ECNs and promotions in OnePLM.
• Monitor SICR KPIs and support global SICR initiatives.

Skills

GMP knowledge

ISO 13485 knowledge

21 CFR Part 820 knowledge

Continuous improvement

PPAP

MSA

SPC documentation

IQ/OQ/PQ validation

PFMEA & Control Plan

Manufacturing processes (welding, MOLD

Education

Honors Bachelor's degree in Engineering or Science

Tools

OnePLM

Job description

Stryker Corporation is seeking a qualified professional to support the SICR process, implement improvements, and maintain the electronic systems in OnePLM. The role requires collaboration with global suppliers and cross-functional teams to ensure timely change execution.

The candidate should have a strong background in manufacturing, GMP/ISO standards, and experience with PPAP, MSA, and PFMEA. Travel up to 10% may be required.