Stryker Corporation

Staff Design Quality Engineer (Software/Electrical)

Stryker Corporation$89K — $148K *
Healthcare
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in Software Engineering, Electrical Engineering, or Computer Science Engineering.
  • 4+ years' experience in quality, manufacturing, new product development, software, or engineering.
  • Experience in the medical device/manufacturing industry is preferred.
  • Familiarity with ISO 13485, ISO 14971, and IEC-62304 standards.
  • Proficiency in data analysis and statistical tools, such as Minitab.
  • Demonstrated knowledge of Advanced Quality tools and the ability to interpret CAD drawings.
  • Six Sigma Certification and ASQ CSQE certification are preferred.

Responsibilities

  • Partner with R&D to ensure product designs meet quality and safety requirements.
  • Collaborate with Product Security to align product designs with cybersecurity practices.
  • Lead risk management activities for new product development teams.
  • Ensure robust process controls in collaboration with Operations and suppliers.
  • Participate in design reviews and track risk mitigation strategies throughout development.
  • Lead design validation activities, including human factors usability engineering.
  • Support the transfer of product design and quality to manufacturing facilities.

Benefits

  • Work flexibility with onsite requirements.
  • Opportunities for career development within a leading medical device company.
  • Collaborative work environment with cross-functional teams.
  • Engagement in high-impact projects that improve patient's lives.
Full Job Description
Work Flexibility: Onsite

Stryker is hiring a Staff Design Quality Engineer (Software/Electrical) in Portage, Michigan to support our Medical business. In this role, you will provide on-site quality support for new product development and partner with cross-functional teams, including R&D, Operations, Product Security, Testing, and Regulatory, throughout the development process. You will develop electrical and software development plans, support execution of those plans, and provide post-market quality support through the change control process. You may also support quality improvement projects.

What you will do:
  • Partner closely with R&D to ensure product designs meet quality requirements for safety and effectiveness. Support the collection of market feedback to inform design requirements and validate the design with customers as it matures through the production launch.
  • Work closely with Product Security and R&D teams to accomplish product security activities and ensure the design is in line with the cybersecurity required practices.
  • Lead risk management activities for new product development teams by developing risk management plans and reports, conducting risk reviews, and verifying the implementation and effectiveness of risk controls.
  • Partner with Operations and suppliers to ensure supplier processes and Stryker manufacturing processes implement robust process controls.
  • Participate in design reviews and track how the design, documentation, and manufacturing process mitigate risks throughout the development process.
  • Lead design validation activities including human factors usability engineering.
  • Support product design and quality transfers to internal and/or external manufacturing facilities.
  • Analyze and define critical quality attributes for products and processes through risk analysis techniques.
  • Contribute to the completion of final design verification and validation reports.
  • Support PPAP planning, communicate PPAP requirements to component suppliers, and support PPAP approval.


What you will need
  • Bachelor's Degree in Software Engineering, Electrical Engineering, or Computer Science Engineering (or other engineering degree with relevant electrical or software experience).
  • 4+ years' experience in quality, manufacturing, new product development, software or engineering.


Preferred
  • Experience within medical device/manufacturing industry.
  • Familiarity with ISO 13485 (medical device standard) and ISO 14971 (risk management standard), IEC-62304 (software development life cycle)
  • Data analysis (statistical analysis, sampling plans, statistical process control, Minitab) experience.
  • Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.
    Demonstrated ability to read and interpret CAD drawings.
  • Six Sigma Certification.
  • ASQ CSQE certification.


United States of America Pay Ranges:
  • USN: $89,300 - $148,800 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.

Travel Percentage: 10%

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

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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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