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.
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.