Stryker · 10 hours ago
Staff Software Engineer- Medical Device Embedded SW (Hybrid)
Portage, MI
Full-time
Hybrid
Senior Level, Lead/Staff
4+ years expStryker is a company that offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics, and Spine. They are seeking a highly experienced Staff Software Engineer to design, develop, and maintain software for safety-critical medical devices, ensuring compliance with FDA and international regulations while leading technical decisions and mentoring engineers.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Lead the design, implementation, and testing of medical device software in compliance with regulatory standards
Develop high-quality, maintainable software using C, C++, Linux, and Qt/QML
Ensure software development activities comply with IEC 62304 (Medical Device Software – Software Life Cycle Processes)
Participate in and support risk management activities in accordance with ISO 14971, including hazard analysis and risk controls related to software
Contribute to system-level requirements, software requirements, and traceability between requirements, design, implementation, and verification artifacts
Collaborate with Quality, Regulatory, Systems Engineering, and Hardware teams to support FDA design controls (21 CFR 820 / Quality System Regulation)
Support software verification and validation activities, including test planning, execution, and documentation
Participate in design reviews, code reviews, and technical risk assessments
Mentor engineers and establish best practices for compliant software development, documentation, and review processes
Qualification
Required
Bachelor's degree in Computer Engineering, Computer Science, Electrical Engineering or related disciplines
4+ years of experience in software engineering, with experience with embedded systems
Extensive professional experience in software engineering with demonstrated staff-level technical leadership
Strong proficiency in C and C++ for embedded and system-level software
Hands-on experience with Qt and QML for application and user interface development
Experience working within a regulated development environment requiring formal documentation, reviews, and traceability
Preferred
Experience with Real-Time Operating Systems (RTOS)
Knowledge of embedded and medical device communication protocols (e.g., UART, SPI, I²C, Ethernet, USB, CAN)
Experience implementing and maintaining CI/CD pipelines in regulated or embedded development environments
Experience with test automation, including unit, integration, and system testing
Familiarity with FDA Design Controls and submissions support (e.g., 510(k), PMA)
Familiarity with IEC 60601 considerations as they relate to software
Familiarity with cybersecurity guidance for medical devices (e.g., FDA premarket cybersecurity guidance)
Benefits
Medical and prescription drug insurance
Dental insurance
Vision insurance
Critical illness insurance
Accident insurance
Hospital indemnity insurance
Personalized healthcare support
Wellbeing program
Tobacco cessation program
Health Savings Account (HSA)
Flexible Spending Accounts (FSAs)
401(k) plan
Employee Stock Purchase Plan (ESPP)
Basic life and AD&D insurance
Short-term disability insurance
Company
Stryker
Stryker is a medical technology company that offers products and services in orthopaedics.
10001+ employees
H1B Sponsorship
Stryker has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (105)
2024 (76)
2023 (63)
2022 (78)
2021 (57)
2020 (77)
Funding
Current Stage
Public CompanyTotal Funding
unknown1990-01-02IPO
Leadership Team
Kevin Lobo
Chair & CEO
Glenn S. Boehnlein
Chief Financial Officer and Vice President
Recent News
GlobeNewswire News Room
2025-02-11
Company data provided by crunchbase