Stryker is hiring a Senior Quality Engineer - New Product Introduction (NPI) to support our Neurovascular division. This is an onsite role based in Salt Lake City, UT. As the Senior Quality Engineer - NPI , you will collaborate across functions to provide quality assurance support for all aspects of New Product Introductions, focusing on long-term strategies for Quality, Risk Management, Inspection & Testing, and Suppliers to ensure product competitiveness and compliance with domestic and international regulations. What You Will Do Support risk management activities by maintaining Risk Management Files, conducting process FMEAs, implementing risk controls, and evaluating process risks throughout the product lifecycle. Ensure compliance with

ISO 14971

requirements and contribute to Critical-to-Quality identification, design risk assessments, and risk management documentation. Develop and execute validation strategies, including Installation Qualification (IQ), Measurement System Analysis (MSA), Operational Qualification (OQ), and Performance Qualification (PQ). Support Production Part Approval Process (PPAP), process validation, test method validation, and First Article Inspection activities for new product introduction projects. Implement inspection and validation approaches that support scalable, compliant, and cost-effective manufacturing processes. Apply statistical methods, process capability analysis, and quality engineering tools to strengthen process performance and support nonconformance and corrective action activities for new products. Collaborate with suppliers by supporting qualification strategies, reviewing validation activities, and providing quality input for supplier selection, certification, and quality agreements. Represent Quality Assurance during design transfer activities, monitor launch quality metrics such as right-first-time performance, inspection costs, and product escape rates, and provide post-launch quality support. What You Need Required Bachelor's degree in Engineering, Science, or a related technical field Minimum 2 years of full-time work experience in Quality Assurance, Quality Engineering, Design Transfer, Manufacturing Engineering, or related functions within the medical device industry Minimum 2 years of full-time work experience in a regulated industry environment Preferred Minimum 2 years of experience in an engineering role within the medical device industry ASQ Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA) certification Experience working with ISO 13485 and

ISO 14971

standards Experience with process validation, test method validation, FMEA, statistical analysis, process capability studies, and Measurement System Analysis (MSA) Experience applying Lean Six Sigma DMAIC methodologies to process improvement initiatives US5 : $81,600 - $136,000 USD Annual