Principal Design Quality Engineer - Digital (Remote)

Stryker•Durham, NJ

14d•Remote

About The Position

Join Stryker’s Design Quality Digital team as a Principal Design Quality Engineer and help shape the future of digital solutions for Trauma, Foot & Ankle, and Upper Extremities portfolios . In this role, you’ll influence product development from concept to launch, ensuring patient safety, product security, and compliance with global standards. Your expertise will drive innovation and quality in life-changing medical technologies. Work Flexibility : This role involves collaborating with global teams, including Europe and India. Flexibility to work across multiple time zones is essential. Preferred locations are CST or EST ; Proximity to Columbia City, IN, or Memphis, TN is a plus but not required.

Requirements

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.

Nice To Haves

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).

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.