Sr Design Quality Manager

Medtronic • Lafayette, CO

1d

About The Position

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 Sr. Design Quality Manager - RPE [Released Product Engineering]. Sr. Design Quality Manager for Released Product Engineering [RPE] within ACM OU. With responsibility for the management of all released product engineering changes across the ACM portfolio of products. The role involves the management of a global Design Quality engineering team focused on RPE product changes. Ensuring the ACM portfolio of products remain state-of-the-art and always available to our customers, as we qualify planned and forced product, packaging, labelling and process changes. In this role, you will be tasked with championing the application of industry leading standards in design controls, Risk Management and Change Control processes, in the evaluation and release of product changes. While continuing to enhance the focus on Patient Safety and Compliance within the global quality team and across our cross functional partners, through collaboration and teamwork. Responsibilities may include. Apply your technical expertise to Put Patients First every day Guide cross-functional teams through the Change Development Process (CDP) with a strong focus on positive design control outcomes and adherence to our QMS. Apply Design for Reliability and Design for Manufacturability principles to reduce risk, improve First Time Quality (FTQ), and enable efficient design transfer. Serve as a subject matter expert in CAPA and Post-Market Surveillance (PMS), ensuring field performance insights are incorporated into product changes. Apply systems engineering principles to coordinate complex, multi-disciplinary product change efforts from concept through commercialization. Leverage 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 Change Development Process and product 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.

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
• Experience leading complex projects/programs
• Experience managing a global team of Quality Professionals
• Experience with Design Control, Change Development processes, CAPA
• 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
• Strong working knowledge of Quality System Regulations such as (QSR 21 CFR 820), and ISO 13485:2016
• Experience creating and maintaining Risk Management Files to the latest ISO 14971 standards.

Nice To Haves

• Familiar with IEC 60601 and product specific industry standards.
• Working knowledge of Electronic Schematics, circuit simulation and analysis, PCB Assembly Drawings.
• Auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive.
• Experience with CAPA and root cause failure analysis.
• Green Belt Six Sigma/DRM Training/Certification
• Demonstrated working knowledge of process validation, statistical methods, risk management
• Experience with Product / Packaging Stability, Biocompatibility, Sterilization, Ship Testing, HALT/HASS.

Responsibilities

• Put Patients First every day
• Guide cross-functional teams through the Change Development Process (CDP) with a strong focus on positive design control outcomes and adherence to our QMS.
• Apply Design for Reliability and Design for Manufacturability principles to reduce risk, improve First Time Quality (FTQ), and enable efficient design transfer.
• Serve as a subject matter expert in CAPA and Post-Market Surveillance (PMS), ensuring field performance insights are incorporated into product changes.
• Apply systems engineering principles to coordinate complex, multi-disciplinary product change efforts from concept through commercialization.
• Leverage 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 Change Development Process and product 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

• Medtronic offers a competitive Salary and flexible Benefits Package
• 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: Mid Level