This role provides Quality Engineering support for new product introductions (NPI), ensuring compliant design transfer, robust manufacturing processes, and effective quality assurance activities. The position works closely with Advanced Operations and Design Assurance to execute validations, risk management, inspection strategies, and process excellence activities. The engineer contributes to the successful launch of new products by ensuring all quality requirements are met according to Stryker’s procedures and industry standards.

• Support design transfer activities for new products by applying quality assurance, design control, and Design for Manufacture and Assembly (DFMA) principles.

• Execute product and process validations, equipment qualifications, and related documentation according to NPI procedures.

• Lead or support risk management activities, including pFMEA creation, process-risk evaluation, mitigation planning, and compliance with ISO 14971 (Medical Devices — Application of Risk Management).

• Develop and implement inspection strategies, including lean inspection methods, sampling plans, Measurement System Analysis (MSA), and First Article Inspections (FAI).

• Apply statistical techniques to build robust, predictive quality systems and support nonconformances (NCs) and Corrective and Preventive Actions (CAPAs) for new products.

• Collaborate with suppliers by supporting qualification activities, reviewing validations, and contributing to PPAP (Production Part Approval Process) deliverables.

• Provide quality support during and after design transfer, ensuring product containment, compliance with design specifications, and incorporation of lessons learned.

• Support process and sterilization validations, inspection optimization, and human-factor error-prevention initiatives to ensure safe and reliable product launches.

Required:

• BS degree in Engineering.

• English proficiency.

• Previous experience as a Quality Engineer, including familiarity with manufacturing processes.

• Experience in highly regulated industries, such as Medical Devices or Pharmaceutical; experience in the electronics industry is acceptable but not preferred.

• Hands-on experience with product validations, equipment qualifications, and process validation.

• Knowledge of statistics.

• Practical experience with risk management, including performing inspections beyond documentation.

Desirable:

• CQE (Certified Quality Engineer) certification or equivalent coursework/experience.

• Knowledge of EO (Ethylene Oxide) sterilization.

• Master’s degree, advanced studies, or ongoing continuing education.