Sr Design Quality Manager

* 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.
* 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.

Leverage engineering knowledge to ensure designs meet functional, safety, and efficacy requirements in compliance with medical device standards.**·
** 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.
* Familiar with IEC 60601 and product specific industry standards.
* 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.Working knowledge of Electronic Schematics, circuit simulation and analysis, PCB Assembly Drawings.
** Medtronic offers a competitive Salary and flexible Benefits Package
** A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week:
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, and Simple Steps (global well-being program).The following benefits and additional compensation are available to all regular employees:
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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).Regular employees are those who are not temporary, such as interns.  Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan.

Please note some of the above benefits may not apply to workers in Puerto Rico.

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