Senior Quality Systems Manager, Design & Reliability Manufacturability - Mounds View, MN

Medtronic • Mounds View, MN

110d • $149,600 - $224,400

About The Position

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 enterprise operations 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 office 4-days per week minimum.

Requirements

• 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 Haves

• 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.
• PMP Certification.
• Working knowledge of Quality System Regulations such as (QSR 21 CFR 820), and ISO 13485:2016.
• Manufacturing Experience.
• Green Belt Six Sigma/DRM Training/Certification.
• Effective verbal and written communication, analytical, influencing and interpersonal skills.
• Demonstrated working knowledge of process validation, statistical methods, risk management.

Responsibilities

• Lead enterprise-wide initiatives with emphasis on Design for 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.

Benefits

• Health, Dental and vision insurance.
• Health Savings Account.
• Healthcare Flexible Spending Account.
• Life insurance.
• Long-term disability leave.
• Dependent daycare spending account.
• Tuition assistance/reimbursement.
• Simple Steps (global well-being program).
• Incentive plans.
• 401(k) plan plus employer contribution and match.
• Short-term disability.
• Paid time off.
• Paid holidays.
• Employee Stock Purchase Plan.
• Employee Assistance Program.
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums).
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree