Senior Software Quality Engineer, Design Assurance

Work Flexibility : Hybrid or Onsite

Stryker is hiring a Senior Software Quality Engineer, Design Assurance to support our Medical's Digital Health division and portfolio Software as a Medical Device (SaMD) 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

Designed and tested prototypes and components, applying engineering principles to meet sub-system requirements and support product development.

Conducted root-cause analysis and problem-solving, evaluating solutions against technical and regulatory criteria.

Translated design inputs into engineering specifications, contributing to component-level and system-level architecture and documentation.

Developed software components, estimated development resources, and led code reviews to ensure alignment with design standards and best practices.

Collaborated cross-functionally with R&D, Quality, Regulatory, and Marketing teams to drive project success and ensure compliance with design controls and risk management processes.

Created and maintained engineering documentation, including Design History Files, in accordance with medical device regulatory standards.

Demonstrated strong understanding of clinical use cases, customer needs, and product requirements to inform design decisions.

Adapted quickly to new systems and processes, showing initiative, ownership, and the ability to prioritize tasks with minimal supervision.

Who we want

Required

Bachelor's degree in a science or engineering.

Minimum of 2+ years of experience working in a highly regulated industry in following cGMP and GDP regulations in the areas of Research & Development (R&D), Quality (QA / QC), Software Engineering, Information Technology, Healthcare IT or Systems Engineering

Preferred

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

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

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

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.

Proven ability to influence design quality across global, multidisciplinary teams.

Knowledge from using Application Lifecycle Management / Traceability tools.

87,600.00 to 186,700.00 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.

Travel Percentage : 20% 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 Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

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