Principal Design Quality Engineer - Digital (Remote) - Indiana, Columbia City 4375 E Park 30 Drive

Work Flexibility: Remote or Hybrid or Onsite

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.

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.