About the role

Aplyr's Quick Take

This role is for a Senior Quality Engineer focused on New Product Introductions in the medical device sector. Day-to-day tasks include risk management, compliance checks, and collaboration with cross-functional teams to ensure product quality and regulatory adherence. It's primarily an individual contributor role with a strong emphasis on quality assurance processes.

Good fit

Ideal candidates have at least 2 years of experience in quality engineering within the medical device industry and a solid understanding of regulatory requirements. A proactive, detail-oriented approach and the ability to work collaboratively are essential.

Worth noting

The position is strictly onsite in Salt Lake City, which may limit flexibility for some candidates. The salary range is quite broad, indicating potential for negotiation based on experience.

Work Flexibility: Onsite

Stryker is hiring a Senior Quality Engineer - New Product Introduction (NPI) to support our Neurovascular division. This is an onsite role based in Salt Lake City, UT.

As the Senior Quality Engineer - NPI, 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

Support risk management activities by maintaining Risk Management Files, conducting process FMEAs, implementing risk controls, and evaluating process risks throughout the product lifecycle.
Ensure compliance with ISO 14971 requirements and contribute to Critical-to-Quality identification, design risk assessments, and risk management documentation.
Develop and execute validation strategies, including Installation Qualification (IQ), Measurement System Analysis (MSA), Operational Qualification (OQ), and Performance Qualification (PQ).
Support Production Part Approval Process (PPAP), process validation, test method validation, and First Article Inspection activities for new product introduction projects.
Implement inspection and validation approaches that support scalable, compliant, and cost-effective manufacturing processes.
Apply statistical methods, process capability analysis, and quality engineering tools to strengthen process performance and support nonconformance and corrective action activities for new products.
Collaborate with suppliers by supporting qualification strategies, reviewing validation activities, and providing quality input for supplier selection, certification, and quality agreements.
Represent Quality Assurance during design transfer activities, monitor launch quality metrics such as right-first-time performance, inspection costs, and product escape rates, and provide post-launch quality support.

What You Need

Required

Bachelor’s degree in Engineering, Science, or a related technical field
Minimum 2 years of full-time work experience in Quality Assurance, Quality Engineering, Design Transfer, Manufacturing Engineering, or related functions within the medical device industry
Minimum 2 years of full-time work experience in a regulated industry environment

Preferred

Minimum 2 years of experience in an engineering role within the medical device industry
ASQ Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA) certification
Experience working with ISO 13485 and ISO 14971 standards
Experience with process validation, test method validation, FMEA, statistical analysis, process capability studies, and Measurement System Analysis (MSA)
Experience applying Lean Six Sigma DMAIC methodologies to process improvement initiatives

US5: $81,600 - $136,000 USD Annual

Travel Percentage: 20%

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.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

Aplyr's read

Stryker excels in medical technology, attracting professionals passionate about innovation in orthopedics, surgical, and neurotechnology solutions.
Synthesized from recent postings & public sources

What's promising

•Stryker's innovative products lead advancements in orthopedics and neurotechnology.
•Global presence offers diverse career opportunities across multiple regions.
•Strong focus on research and development fosters continuous innovation.

What to watch

•High competition in the medical technology sector may impact market share.
•Regulatory challenges can affect product launch timelines.
•Complex organizational structure may slow decision-making processes.

Why Stryker

•Stryker's commitment to innovation in medical technology sets it apart.
•Diverse product range across orthopedics, surgical, and neurotechnology.
•Strong emphasis on employee development through varied roles and internships.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Stryker

Stryker

stryker.com

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Stryker is a global leader in medical technology, offering innovative products and services in orthopedics, medical and surgical, and neurotechnology and spine.