Manager, Product Design Quality

As the Manager of Product Design Quality at Stryker, you will oversee a dedicated team managing the quality of SaMD/SiMD products within the Medical Division. Your primary responsibilities will involve collaborating with cross-functional teams to ensure product quality, managing risk assessments, and ensuring compliance with regulatory standards while driving continuous process improvements.

To be considered for the Manager of Product Design Quality role at Stryker, candidates must possess a Bachelor’s degree in an Engineering discipline, along with a minimum of 8 years of experience in the medical device industry. Additionally, having at least 1-3 years of leadership experience in a regulated environment, along with expertise in risk management and software quality processes, is essential.

Stryker is committed to fostering professional growth for the Manager of Product Design Quality by providing mentorship opportunities, defining clear team objectives aligned with business goals, and offering performance feedback. Employees are encouraged to pursue personal development through strategic assignments and coaching that support their career advancement.

In the Manager of Product Design Quality position at Stryker, you can expect a hybrid work environment that blends office presence and remote work. The work schedule is structured for flexibility, with in-office days required Monday through Wednesday, allowing employees to work from home on Thursdays and Fridays while still engaging with team members and stakeholders.

The salary for the Manager of Product Design Quality role at Stryker ranges from $115,600 to $245,800, plus eligibility for bonuses and excellent benefits. This compensation varies based on location, skills, experience, and other relevant factors—ensuring that individual pay is reflective of what each candidate brings to the team.

When answering this question, highlight your understanding of risk assessment methodologies like dFMEA/sFMEA. Explain how you applied these in past roles, and be specific about the impact your management had on product development and safety.

To successfully lead a quality engineering team, emphasize the importance of clear communication, establishing team objectives, and fostering a culture of collaboration and continuous improvement. Highlight examples of how you’ve mentored team members and encouraged their career growth.

Discuss your familiarity with specific regulations like FDA and International Medical Device Regulations. Share a concrete example of a project where you ensured compliance successfully and outline the strategies you implemented to manage audits and regulations.

A strong response will include specific processes you've handled for verification and validation in previous projects. Mention how you collaborated with various stakeholders to ensure product quality at each stage of development.

Frame your answer around a specific instance where you implemented changes that enhanced process efficiency. Discuss the tools or methodologies you’ve used, and how they’ve positively impacted product quality and team performance.

Detail your experience with software change management tools such as Jira, Bitbucket, or others relevant to your past roles. Explain their importance in handling defects and facilitating smoother product releases.

Explain your systematic approach to preparing for audits, from documentation to coaching your team on compliance standards. Share an experience where your preparation led to successful outcomes during audits.

Discuss how collaboration among departments leads to better outcomes in product design quality. Provide examples of how working closely with the Marketing and R&D teams improved product performance and reduced time-to-market.

Convey your passion for improving health technologies and how they can make a quantitative difference in lives. Share personal motivations and visions for the future of digital health that highlight your commitment to the industry.

Mention specific resources, such as professional organizations, conferences, webinars, or industry publications that you follow to stay current. Share how you apply this knowledge to your work and decision-making processes.