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Stryker is growing! We are hiring a **New Product Introduction (NPI) Senior Quality Engineer** in **Salt Lake City, Utah** , to support **Neurovascular** ! In this role, 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:

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 & Validation:

+ Support PPAP, process validation, and test method validation.

+ Develop and implement lean inspection and validation strategies to ensure scalable, compliant, and cost-optimized processes.

+ Support First Article Inspections (FAI), develop MSA strategy, and promote validation over manual verification.

Process Excellence:

+ Apply statistical techniques to develop robust, predictive quality systems that are transferable and maintainable in production, including support for NCs and CAPAs in new products.

+ Support Design for Manufacture and Assembly (DFMA) through process design, inspection optimization, and prevention of human factor errors.

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), ensuring launch targets (RFT, inspection costs, product escapes) are met, while providing audit and post-launch quality support.

What you need

Required:

+ Bachelor of Science, Engineering or related subject.

+ 2+ years in Quality Assurance, Engineering, Design Transfer/Manufacturing Transfer.

+ Regulated industry experience required.

Preferred:

+ Experience preferably in the medical device industry.

+ ASQ-CQE, CQA experience desired.

+ ISO 13485 and ISO 14971.

+ Experienced in Validations, 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.

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.