Job Description

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.

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