We anticipate the application window for this opening will close on - 15 Oct 2025

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

The Senior Quality Systems Manager drives the evolution of Medtronic’s product development processes to set new industry-leading standards serving as a domain expert in Design Control. Lead our team by coaching internal customers across our diverse product portfolio, to elevate Design Control capabilities throughout the organization. In this role, you will proactively identify and implement large-scale initiatives that enhance rigor, productivity and user experience by leveraging cutting-edge technologies and innovative methodologies.


This is an on-site position that requires candidates to work in the Mounds View, MN, Lafayette, CO, Boston, MA, Memphis, TN, or Santa Rosa, CA office 4-days per week minimum.

Responsibilities may include the following and other duties may be assigned.

• Lead enterprise-wide initiatives with emphasis on Design, Reliability & Manufacturability (DRM) to ensure product quality, regulatory compliance and operational excellence across all Medtronic Operating Units (OU). 

• Apply your technical expertise to Put Patients First every day 

• Apply Design for Reliability and Design for Manufacturability principles to reduce risk, improve First Time Quality (FTQ), and enable efficient design transfer. 

• Guide cross-functional teams through the Product Development Process (PDP) with a strong focus on positive design control outcomes and regulatory adherence. 

• Serve as a subject matter expert in CAPA and Post-Market Surveillance (PMS), ensuring field performance insights are incorporated into early design phases. 

• Apply systems engineering principles to coordinate complex, multi-disciplinary product development efforts from concept through commercialization. 

• Leverage biomedical engineering knowledge to ensure designs meet functional, safety, and efficacy requirements in compliance with medical device standards. 

• Maintain deep familiarity with FDA 21 CFR Part 820, ISO 13485, and other design-controlled regulations, providing expert guidance on compliance throughout the development lifecycle. 

• Partner closely with R&D and Quality colleagues to embed best practices in technical rigor, simplify execution, and bring forward individual perspectives that strengthen decision-making and solution design. 

Must Have: Minimum Requirements  

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.  

• Bachelor’s Degree with 7+ years of work experience in Quality, with 5+ years of managerial experience  

• OR Advanced Degree with 5+ years of work experience in Quality with 5+ years of managerial experience 

 

Nice to Have: Preferred Qualifications 

• Experience leading complex projects/programs 

• Experience with SPC, CAPA, NCMR, PDP processes 

• Effective planning and organization skills including the proven ability to work against multiple objectives simultaneously 

• Ability to establish and maintain a trusted role with the various stakeholders in coordinating multiple functions across the organization