Staff Quality Engineer - New Product Introduction

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.