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**Stryker** is hiring a **Senior Staff Hardware Development Quality Engineer** 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.

**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. 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:

+ Led advanced prototyping, testing, and research initiatives, translating user needs into robust design inputs and engineering specifications for complex systems.

+ Solved intricate design challenges independently, balancing trade-offs and applying sound judgment to optimize component and sub-system performance.

+ Designed and developed software systems, estimated development resources, and conducted code reviews to uphold architectural integrity and coding standards.

+ Authored and reviewed comprehensive project documentation, including requirements, architecture, test plans, and defect tracking, ensuring alignment across teams.

+ Applied deep understanding of clinical workflows and customer needs to inform design strategy and support Voice of Customer sessions with internal and external stakeholders.

+ Led compliance efforts, mentoring peers on regulatory standards, design controls, and risk management practices within the Quality Management System.

+ Influenced cross-functional teams across R&D, Regulatory, Clinical, and Marketing, driving product development from concept through launch with strategic leadership.

+ Championed process improvements and innovation, identifying opportunities to enhance procedures, systems, and technologies while delivering high-impact results.

Who we want:

Required:

+ Bachelor’s degree in a science or engineering.

+ Minimum of 6+ 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, Biomedical Engineering, Software Engineering, Computer Science or a related discipline.

+ 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.

+ Experience with AI-enabled, wearable, or sensor-based platforms.

+ Strong understanding of cybersecurity, interoperability, and data integrity for connected devices.

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

+ Knowledge from using Application Lifecycle Management /Traceability tools.

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.