Stryker is hiring a **Staff Quality Engineer - New Product Introduction (NPI)** in **Salt Lake City, Utah** to support **Neurovascular** ! In this role, you will 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** Inter-organization Collaboration: + Build collaborative internal/external professional relationships across Design Divisions & GQO functions associated with design transfer activities. Risk Management: + Support the Risk Management File, evaluating process risks, implementing mitigation strategies, and ensuring controls are in place throughout the product lifecycle (from materials to product release) via robust pFMEA. + Ensure compliance with ISO 14971 for all risk management outputs and collaborate on CQA/CTQ identification and dFMEA inputs. Inspection: + Develop and implement lean inspection strategies and lead continuous improvement to enhance efficiency, scalability, and error reduction. + Lead and approve First Article Inspections (FAI) and develop Measurement System Analysis (MSA) strategy, ensuring product integrity and cost optimization. Validation: + Support the development and approval of validation strategies, ensuring high-yield processes with scalability and compliance. + Promote process validation over manual verification and support sterilization validation activities. Process Excellence: + Apply statistical techniques to develop robust, predictive quality systems that are transferable and maintainable in production. + Provide expertise for NCs and CAPAs related to new products, mentoring in problem-solving and root cause analysis. + Support Design for Manufacture and Assembly (DFMA) through process design, inspection optimization, and human factor error prevention. Purchase Controls: + Support supplier qualification strategy, approve supplier validations, and ensure scalable, capable processes meet Stryker expectations. + Provide Quality input for supplier selection, certification, and establishing Quality Agreements for NPI projects. Design Transfer: + Represent Quality Assurance in the Design Transfer Agreement Plan (DTAP) process to ensure product launches meet key targets like RFT, inspection costs, and product escapes. + Provide subject matter expertise in design transfer, participate in audits, and lead lessons learned and post-launch quality support. **What you need** **Required:** + Bachelor of Science, Engineering or related subject. + 4+ years in Quality Assurance or related functional area such as Design Transfer/Manufacturing Transfer. + Regulated industry experience required. **Preferred:** + Master of Science, Engineering or related subject is a plus. + Experience preferably in the medical device industry. + ASQ-CQE, CQA experience desired. + ISO 13485 and ISO 14971. + Familiarity with extrusion processes and laser cutting techniques is a plus. + Experience with supplier qualification processes + Highly proficient in all aspects of Validation. + Experienced in risk-based and statistical techniques such as FMEA, statistical sampling, process capability, and Measurement System Analysis. + Skilled in using Lean Six Sigma (DMAIC) to solve complex design, process, and technical issues. + Strong analytical, organizational, and multitasking abilities. + Effective communicator and collaborator with multidisciplinary teams. Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role. 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.