Work Flexibility: Onsite 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 Travel Percentage: 20% Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability. Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.