Overview
Engineer Validation supports new product and process introductions and drives validation activities for manufacturing systems, software, automation solutions, and digital tools.
What you'll do
- Support new product and process introductions under Stryker’s Product Development Process (PDP) and quality system requirements.
- Support Computer System Validation (CSV) for manufacturing systems, software applications, automation solutions, and digital tools.
- Develop and execute validation documentation, including validation plans, risk assessments, test protocols, and reports.
- Design, execute, and document process qualifications, equipment qualifications, and validation activities (IQ/OQ/PQ).
- Review, approve, and maintain validation and technical documentation.
- Collaborate with Quality Engineering to define inspection methods, test protocols, and acceptance criteria.
- Conduct risk management (PFMEA, Control Plans, SOPs, and PPAP documentation) and perform MSA and capability studies.
What you'll need
- Minimum 2 years of engineering experience in medical device, regulated manufacturing, or a similar high-technology environment.
- Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related technical discipline.
- Strong understanding of manufacturing processes, equipment qualification, and process validation methodologies.
- Knowledge of quality and regulatory requirements, including GMP, FDA, ISO 13485, and risk management.
- Ability to interpret engineering drawings, specifications, and GD&T.
- Experience with statistical tools, process capability analysis, and root-cause problem-solving.
Nice to have
- Strong project management, organizational, and multitasking skills.
- Excellent communication and interpersonal skills for collaboration across multidisciplinary teams.
- Self-motivated, results-oriented with a continuous improvement mindset.
- High attention to detail and commitment to product quality and patient safety.
Details
- Work flexibility: Hybrid or Onsite.
- Travel percentage: 20%.
Read the full description and apply on the company’s own careers page.
