Senior NPI Quality Engineer

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.