Principal Design Quality Engineer – Digital

November 18

🏖️ New Jersey – Remote

Although this job is listed in New Jersey, this company may be open to hiring remote in other states.

🌲 North Carolina – Remote

Although this job is listed in North Carolina, this company may be open to hiring remote in other states.

+1 more states

🏖️ New Jersey – Remote 🌲 North Carolina – Remote 🎸 Tennessee – Remote

💵 $115.6k - $245.8k / year

⏰ Full Time

🔴 Lead

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

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Stryker

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Healthcare Insurance • Medical Devices • Biotechnology

Stryker is a global leader in medical technology, providing innovative products and services across the healthcare sector. With a presence in countries across the Americas, Asia Pacific, Europe, and the Middle East & Africa, Stryker offers a wide range of medical technologies, including orthopedic implants, surgical equipment, and advanced hospital devices. The company is committed to improving patient outcomes and healthcare efficiency. Stryker continues to expand its global reach, offering localized solutions to meet diverse healthcare needs worldwide.

10,000+ employees

Founded 1941

⚕️ Healthcare Insurance

🧬 Biotechnology

📋 Description

• 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

🎯 Requirements

• Bachelor’s degree in science or engineering required; preferred 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 • Master’s degree in a related field preferred • Experience with security risk management processes in healthcare or medical devices preferred • Familiarity with programming languages, embedded software tools, and Agile methodology preferred • Direct experience in vulnerability management and defect review preferred • One or more active, industry-recognized cybersecurity certifications preferred • Understanding of NIST, ISO, and related security frameworks, particularly in vulnerability management preferred • 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) preferred.

🏖️ Benefits

• Eligible for bonuses • Health insurance • Retirement plans