Stryker Corporation

Senior Quality Engineer - NPI (Onsite)

Stryker Corporation$81K — $136K *
Healthcare
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering, Science, or related technical field
  • 2+ years in Quality Assurance or related fields within medical device industry
  • 2+ years in a regulated industry environment
  • Preferred: 2+ years in engineering role in medical devices
  • Preferred: ASQ Certified Quality Engineer or Certified Quality Auditor
  • Preferred: Experience with ISO 13485 and 14971 standards
  • Preferred: Familiarity with Lean Six Sigma DMAIC methodologies

Responsibilities

  • Support risk management by maintaining Risk Management Files and conducting process FMEAs
  • Ensure ISO 14971 compliance and contribute to design risk assessments
  • Develop validation strategies including IQ, OQ, and PQ
  • Support PPAP, process validation, and First Article Inspection activities
  • Implement inspection and validation approaches for manufacturing processes
  • Apply statistical methods and quality engineering tools for process performance improvement
  • Collaborate with suppliers to ensure quality input and compliance during product launch

Benefits

  • Opportunity for onsite collaboration in Salt Lake City, UT
  • Engagement in cross-functional collaboration for product launches
  • Involvement in long-term strategies for quality and compliance
  • 20% travel for supplier and industry engagement
  • Access to ongoing quality assurance support and resources
Full Job Description
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%

About Stryker Corporation

Stryker Networks is a premier Information Technology partner providing IT managed services and database application development.

Stryker Corporation Careers

Joining Stryker Corporation means becoming part of a global team recognized for its commitment to innovation, leadership, and enhancing patient outcomes. As a leading medical technology company, Stryker is the perfect place to build a career that truly makes a difference.

Work You’ll Do

At Stryker, every position contributes to our mission of making healthcare better. Here, you will use your skills to work on transformative projects that improve lives across the globe. You will be part of a culture that thrives on growth, innovation, and leadership, and you will work alongside some of the brightest minds in the industry.

Innovative Careers

Stryker offers a range of job opportunities, from internships that provide a stepping stone into high-impact roles to leadership positions that drive strategic direction. Our team members benefit from a work environment that supports professional growth and diversity training, ensuring everyone, regardless of background, can thrive.

Be Part of a Great Team

Our employees enjoy a collaborative atmosphere that fosters innovation and encourages professional development. With a commitment to leadership and diversity, Stryker ensures that all team members have the opportunity to grow and influence the company's future. Our global scale and dedication to impactful solutions make us leaders in medical technology.

Future-Proof Your Career

Stryker is dedicated to career development, offering extensive training, benefits, and resources to help you advance professionally. From networking opportunities to workshops on resume and interview skills, we support your journey every step of the way. Our career paths are as diverse as the innovative products we develop and the markets we serve.

Explore Job Opportunities

Whether you’re just starting out or looking to take your career to the next level, Stryker provides the tools and resources to achieve your goals. We are continuously hiring and looking for ambitious, curious, and driven individuals to join our team.

Stryker Corporation – A Leader in Medical Technology

Our commitment to improving healthcare through innovative products sets us apart in the medical technology field. The synergy of our team’s expertise and our leadership in technology solutions enables us to meet the needs of our customers effectively.

Stay Connected

Join Our Team Search open positions that match your skills and interest. We look for passionate, creative, and solution-driven team players. Explore the many benefits of employment at Stryker, a company that values innovation and leadership.

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Learn more about Stryker Corporation
Size
46,000 employees
Market Cap
$91.9 billion
Industry
Net Income
$1.5 billion
Founded
2004
5 Year Trend
+8.6%
Revenue
$14.3 billion
NASDAQ

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