Staff Software Quality Engineer, Design Assurance

Stryker • Fort Wayne, IN • 2d ago

Stryker is hiring a Staff Software Quality Engineer, Design Assurance to support our Medical's Digital Health 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; Orlando, FL; Portage, MI; or Fort Wayne, IN. The work schedule is structured to support flexibility, with in-office presence required Monday through Wednesday and remote work available on Thursday and Friday. To qualify, candidates must be able to commute to one of these specific facilities as needed.

What you will do:

Execute quality assurance activities for new product development within Stryker's global Digital Health Portfolio, focusing on Acute Care in the Medical Division.

Collaborate on software design, development, and validation strategies, ensuring documentation aligns with Quality Management Systems compliance requirements.

Partner with cross-functional teams, including marketing, R&D, clinical, regulatory, and operations, to deliver quality, compliant products.

Oversee risk management using ISO14971 standards to ensure product safety, including defining critical quality attributes, assessing residual risks, and presenting risk/benefit justifications to executive leadership.

Drive continuous improvement across the software lifecycle by implementing software industry best practices and regulatory standards (FDA, TGA, EUMDR, IT).

Engage in design and development activities for both medical and non-medical software, including SaMD, MDDS, and AI/ML solutions.

Implement standard development practices, promoting methodologies like SAFe for mobile and cloud-based solutions to enhance efficiency and compliance.

Ensure cybersecurity, data privacy, and interoperability are integrated into digital product design, reviewing software artifacts for compliance and traceability.

What you need:

Required:

Bachelor's degree in a science or engineering.

Minimum of 4 years of experience working in a highly regulated industry in the areas of Research & Development (R&D), Quality (QA/QC), Software Engineering, Information Technology, Healthcare IT or Systems Engineerin

Experience working through software lifecycle processes (Agile SAFe/Waterfall).?

Experience with software Failure Modes Effect Analysis (sFMEA), Security Risk Assessments and defect management, software verification/validation.

Preferred:

Bachelor's degree in Computer Engineering, Electrical Engineering, Software Engineering, or Computer Science.

Previous employment at leading technology companies such as Amazon, Google, Microsoft, or similar, demonstrating strong technical skills

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.

Experience with software technologies for mobile, cloud, and AI/ML solutions, including Amazon AWS, Microsoft Azure, Apple, or Android platforms

Cybersecurity certification (e.g., CISSP, Security+, or equivalent) or demonstrated experience in secure software development, with a strong foundation in risk management methodologies and the creation and maintenance of detailed Failure Modes and Effects Analyses (FMEAs).

100,500.00 to 215,300.00 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

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

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