Engineer Validation

About the role

Join Stryker as an Engineer Validation, supporting new product and process introductions within a regulated medical device environment. You will work on validation activities for manufacturing systems, software applications, and automation solutions, ensuring compliance with regulatory and quality standards.

Key responsibilities

• Support new product and process introductions in line with Stryker’s Product Development Process and quality system requirements.
• Perform Computer System Validation (CSV) for manufacturing systems, software applications, and digital tools.
• Develop and execute validation documentation, including plans, risk assessments, test protocols, and reports.
• Design, execute, and document IQ/OQ/PQ for equipment and processes.
• Review, approve, and maintain validation and technical documentation.
• Collaborate with Quality Engineering to define inspection methods, test protocols, and acceptance criteria.
• Support risk management activities such as PFMEA, Control Plans, SOPs, and PPAP documentation.
• Conduct Measurement System Analysis (MSA) and capability studies for new products and processes.
• Ensure compliance with GMP, FDA, ISO 13485, safety, and environmental requirements.

Required profile

• Bachelor's degree in Mechanical, Manufacturing, Industrial Engineering or related field.
• Minimum 2 years of engineering experience in medical device or regulated manufacturing environment.
• Strong understanding of manufacturing processes, equipment qualification, and validation methodologies.
• Knowledge of GMP, FDA, ISO 13485, and risk management principles.
• Ability to interpret engineering drawings, specifications, and GD&T.
• Experience with statistical tools, process capability analysis, and root‑cause problem‑solving.

Required skills

• Computer System Validation (CSV)
• IQ/OQ/PQ execution
• Risk assessment and PFMEA
• Measurement System Analysis (MSA)
• Statistical analysis tools
• Geometric Dimensioning & Tolerancing (GD&T)
• Regulatory knowledge (GMP, FDA, ISO 13485)