Stryker · 4 hours ago
Principal Design Quality Engineer - Digital (Remote)
United States
Full-time
Remote
Senior Level, Lead/Staff
$116K/yr - $246K/yr
8+ years expStryker is a leading company in the medical technology field, and they are seeking a Principal Design Quality Engineer to join their Design Quality Digital team. In this role, you will influence product development from concept to launch, ensuring patient safety and compliance with global standards while driving innovation in medical technologies.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Provide design controls expertise throughout product development, ensuring successful design transfer
Develop and implement risk management strategies for product and cybersecurity to safeguard patient safety
Interpret and apply industry standards and regulations to establish world-class quality processes
Lead and mentor teams to build robust software architecture aligned with regulatory requirements
Drive development and utilization of tools and systems that enhance product and process performance
Facilitate internal and external audits to maintain compliance with global quality standards
Guide product development teams through vulnerability assessments within defined security risk frameworks
Communicate security initiatives and process improvements to leadership and stakeholders across global teams
Qualification
Required
Bachelor's degree in science or engineering required; preferred to be in Software Engineering, Computer Science, Electrical Engineering, System Engineering, Product Security or mathematics
Minimum 8 years of related experience, including at least 4 years in new product development or software/systems quality engineering activities within a highly regulated environment
Demonstrated knowledge of security control frameworks, risk assessments, and threat scoring
Preferred
Master's degree in a related field
Experience with security risk management processes in healthcare or medical devices
Familiarity with programming languages, embedded software tools, and Agile methodology
Direct experience in vulnerability management and defect review
One or more active, industry-recognized cybersecurity certifications
Understanding of NIST, ISO, and related security frameworks, particularly in vulnerability management
Knowledge of medical device regulations (e.g., US FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601-1, FDA 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
Chief Executive Officer
Glenn S. Boehnlein
Chief Financial Officer and Vice President
Recent News
GlobeNewswire News Room
2025-02-11
Company data provided by crunchbase