Stryker Corporation

New Product Development Quality Engineer

Stryker Corporation$70K — $95K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in mechanical engineering, industrial engineering, or related field.
  • 3+ years of quality engineering experience specifically in the medical device sector.
  • Strong knowledge of GD&T for CNC machined components.
  • Hands-on experience with ISO 13485 and CAPA processes.
  • Proficient in statistical software, such as Minitab, and metrology equipment usage.
  • Certification as an ASQ Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt is preferred.

Responsibilities

  • Collaborate with engineers to create quality plans for new medical components.
  • Lead FMEAs to identify and minimize risks in CNC machining.
  • Oversee inspection qualifications and validations for new processes and equipment.
  • Develop complex geometric inspection methodologies using advanced tools.
  • Ensure compliance of project documentation to ISO 13485 and FDA regulations.
  • Coordinate with suppliers to ensure incoming components meet specifications.
  • Apply Six Sigma and Lean methodologies to enhance production efficiency.

Benefits

  • Opportunity to lead quality assurance in innovative medical technologies.
  • Engagement with cross-functional teams, enhancing professional collaboration.
  • Involvement in high-stakes product development with significant impact.
  • Career growth potential in a regulated field with stringent quality standards.
  • Access to advanced tools and technologies in quality control.
Full Job Description
Description

This is a critical role where engineering meets compliance. You will serve as the quality lead for new product launches, ensuring that every machined component-from prototype to full-scale production-meets the rigorous standards of the medical device industry.
Key Responsibilities:
  • Collaborate with design and manufacturing engineers to develop quality plans for new medical components.
  • Lead and participate in Design and Process FMEAs to identify and mitigate potential failure modes in CNC machining processes.
  • Oversee IQ/OQ/PQ activities for new equipment and validated processes.
  • Develop inspection methodologies for complex geometries, including the use of CMM, vision systems, and precision hand tools.
  • Ensure all project documentation complies with ISO 13485 and FDA 21 CFR Part 820 standards.
  • Work with raw material and coating suppliers to ensure incoming components meet technical specifications.
  • Utilize Six Sigma and Lean tools to optimize yields and reduce scrap during the transition from R&D to production.


Requirements

  • Bachelor's degree in mechanical engineering, industrial engineering, or a related technical field.
  • 3+ years of quality engineering experience within the medical device industry.
  • Strong understanding of GD&T (Geometric Dimensioning and Tolerancing) and its application in CNC machined parts.
  • Hands-on experience with ISO 13485 and the CAPA process.
  • Proficiency with statistical software (like Minitab) and experience with high-precision metrology equipment.
  • ASQ Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt is a plus.

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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Stryker Corporation – Where Talent Meets Opportunity

At Stryker, we believe in turning the challenges of today into the breakthroughs of tomorrow. Join us in our mission to improve healthcare around the world.
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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