Principal Design Quality Engineer - Digital (Remote)

Why engineering at Stryker?

At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.

Need another reason to apply? Check out these 8 reasons to join Stryker's engineering team:

We are proud to be named one of the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

Stryker is hiring a Principal Design Quality Engineer for our Design Quality Digital group for Stryker T&E digital product portfolios (Trauma, Foot & Ankle, Upper Extremities). The position requires strong partnership with product development teams to ensure time-to-market, customer requirements, and technology objectives are met while ensuring compliance to global quality and regulatory requirements.

Location: This role involves collaborating with teams worldwide, spanning Europe and India. Flexibility to work across various time zones is essential. Therefore, someone who sits in either CST, EST or Columbia City, IN or Memphis, TN are preferred.

What you will do:

• Provide Design Controls expertise for product development projects from inception through successful Design Transfer.
• Develop and implement appropriate product and security Risk Management strategies and programs to ensure patient safety and product security.
• Divisional expert interpreting industry standards and government regulations to drive implementation of world class processes that may provide resources and/or help to remove obstacles to team accomplishments.
• Assist in facilitation of internal and third-party audits as needed.
• Influence, lead and mentor the team to develop robust software architecture as per quality and regulatory requirements and guide related tradeoff decisions.
• Team expert, who leads development and utilization of tools & systems which enhance the company's product/process development and performance.
• Mentor and grow technical talent within Design Quality Digital.
• Influence, lead and mentor teams to establish, implement, and maintain processes and documents supporting our global and divisional QMS.
• Effectively communicate global and divisional initiatives to leadership and stakeholders at all levels within the division across business units, while delivering presentations and communications that clearly articulate security topics up to senior leadership. Additionally, recommend efficiency and process improvements to enhance product security capabilities and functions.
• Provide product security guidance and leadership to internal taskforce teams.
• Guide product development teams in completing overall vulnerability assessments within a defined security risk management process.

What you need:

Required

• Bachelor's degree in a science or engineering in Software Engineering, Computer Science, Electrical Engineering, System Engineering, Product Security or mathematics.
• Minimum of 9+ years in a highly regulated environment with 4+ years' experience in new product development or Software and/or Systems focus on quality engineering related activities. Strong preference given to medical device industry experience.
• Demonstrated knowledge in applying security control frameworks, risk assessments, and scoring security threats.

Preferred:

• Master's degree preferred.
• Understands security risk management processes preferably in the healthcare or medical device industry.
• Familiarity with basic programming language, embedded software & tools. ands on experience in using Agile methodology.
• Direct experience working in a product focused vulnerability management process and ability to review Defects.
• One or more active, industry recognized, and relevant cybersecurity certifications.
• Demonstrated ability to plan, track and facilitate projects using applicable tools (Gantt, Burndowns, etc.)
• Skilled in identifying vulnerabilities in cloud, distributed applications, embedded systems, and IoT.
• Thorough understanding of NIST, ISO, and related security frameworks, particularly in vulnerability management.
• Medical Device Regulations: US FDA quality regulations 21CFR part 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601-1 family of standards and FDA Cybersecurity guidance (including FD&C 524B and eSTAR updates).

112,800.00 to 239,900.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.
About Stryker

Our benefits:

• 12 paid holidays annually
• Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
• Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits

About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com.

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Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.