Stryker Corporation

Senior Software Quality Engineer, Design Assurance

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

Qualifications

  • Bachelor's degree in science or engineering.
  • 2+ years of experience in R&D, Quality Engineering, Software Quality Engineering, IT, Healthcare IT, or Systems Engineering.
  • Experience in regulated industries adhering to cGMP, GDP, or relevant standards.
  • Preferred Bachelor's degree in Computer Engineering, Electrical Engineering, Software Engineering, or Computer Science.
  • Understanding of software development lifecycle models (Agile SAFe or Waterfall).
  • Experience with software risk assessments, defect management, and verification/validation.
  • Knowledge of medical device regulations and standards (820, IEC 62304/82304, 60601).

Responsibilities

  • Design software components and system elements for scalable product development.
  • Lead problem-solving activities to identify root causes and evaluate design options.
  • Translate design inputs into clear engineering specifications and documentation.
  • Develop software modules and facilitate design/code reviews for quality alignment.
  • Collaborate with R&D, Quality, Regulatory, and Marketing teams on design decisions.
  • Create and maintain engineering documentation for compliance and traceability.
  • Stay informed about clinical workflows and customer needs to guide design choices.

Benefits

  • Hybrid work arrangement with flexibility for in-office and remote work.
  • Work in a dynamic environment contributing to innovative medical technology.
  • Opportunity to collaborate with multidisciplinary teams in healthcare.
  • Engagement in high-impact projects affecting patient outcomes.
Full Job Description
Work Flexibility: Hybrid or Onsite

Stryker is hiring a Senior Software Design Quality Engineer to support our Medical's SmartCare division and portfolio Software as a Medical Device (SiMD) or Software in a Medical Device (SiMD) to execute on Digital Health projects as a software design quality assurance engineer for pre-market new product development projects.

Workplace Flexibility & Location requirements: This is a hybrid role requiring the candidate to be within commuting distance of one of the following locations: San Jose, CA or Orlando, FL. The work schedule is structured to support flexibility, with in-office presence required 3 days/week and remote work available the rest of the week. To qualify, candidates must be able to commute to one of these specific facilities as needed.

What you will do:
  • Design software components and system elements, applying strong engineering and design principles to meet sub-system requirements and support scalable, high-quality product development.
  • Lead analytical problem-solving activities, identifying root causes and evaluating design options against technical, user, and regulatory constraints to drive robust solutions.
  • Translate design inputs into clear engineering specifications, contributing to both component-level and system-level architecture and high-quality technical documentation.
  • Develop software modules and contribute to architectural planning, providing effort estimates and facilitating design and code reviews to ensure alignment with quality standards and engineering best practices.
  • Collaborate with R&D, Quality, Regulatory, and Marketing, ensuring design decisions align with product strategy, user needs, and medical device design control requirements.
  • Create and maintain comprehensive engineering documentation, including Design History File elements, ensuring traceability, compliance, and long-term maintainability.
  • Stay deeply informed about clinical workflows, customer needs, and operational requirements, using this understanding to guide design choices and enhance product usability and safety.
  • Adapt quickly to new tools, systems, and processes, demonstrating initiative, ownership, and the ability to manage priorities effectively with minimal oversight.


What you need:

Required:
  • Bachelor's degree in a science or engineering.
  • Minimum of 2+ years of experience working in the areas of Research & Development (R&D), Quality Engineering, Software Quality Engineering, Information Technology, Healthcare IT or Systems Engineering.
  • Proven experience working in either leading technology company or highly regulated industries, ensuring adherence to cGMP, GDP, or relevant compliance standards.

Preferred:
  • Bachelor's degree in Computer Engineering, Electrical Engineering, Software Engineering, or Computer Science.
  • Demonstrated ability to operate within various software development lifecycle models, including Agile SAFe or Waterfall.
  • Experience with software Failure Modes Effect Analysis (sFMEA), Security Risk Assessments and defect management, software testing and/or verification/validation.
  • Experience with regulatory agencies (FDA, MoH, TUV) and medical device regulations (820, IEC 62304/82304, 60601), with experience in Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and/or Digital Health Systems and Telehealth Solutions.


United States of America Pay Ranges:
  • USN: $89,300 - $148,800 USD Annual
  • US30: $116,100 - $193,400 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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