Senior Quality Engineering Manager
MedtronicAbout the role
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
As a Senior Quality Engineering Manager in the Cardiac Surgery Post Market Quality organization, you will lead quality strategy and execution for a complex, global commercial portfolio. You will be accountable for ensuring patient safety, product performance, and regulatory compliance for released products, while leading a high‑performing team responsible for post‑market surveillance and risk management.This role requires deep technical expertise in risk management, design controls, and root cause investigation, along with proven leadership capability to drive change, strengthen quality culture, and deliver results in a fast‑paced environment.
At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We are working onsite a minimum of 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects.
Responsibilities may include the following and other duties may be assigned:
- Lead and develop a team of Reliability Engineers supporting all aspects of post‑market quality; manage performance, talent development, and succession planning
- Oversee product and process risk management activities, including hazard analyses, FMEAs, and risk/benefit assessments, aligned with system architecture, clinical intent, and real‑world use
- Lead and/or coach team on investigations into product failures, complaints, and quality signals from the field, applying robust root cause analysis and ensuring timely, effective CAPAs
- Provide Quality leadership and governance for design verification and validation, including review and approval of test strategies, protocols, execution readiness, and results
- Partner cross‑functionally to improve product performance and oversee design and process changes for released products
- Establish and sustain standard work, operating mechanisms, and KPIs to improve execution rigor, visibility, and predictability
- Identify risks, gaps, and improvement opportunities within Quality processes and lead continuous improvement initiatives to enhance compliance, efficiency, and technical rigor
Nice to Have:
- Experience managing a large team preferably in Post Market Quality Engineering, Design Assurance Engineering, or Operations Quality Engineering
- Working knowledge of global regulatory requirements and experience supporting regulatory inspections or audits
- Demonstrated strong influencing skills with the ability to drive alignment and decisions across functions and leadership levels
- Ability to balance technical depth with strategic thinking to drive risk‑based decision making
Requirements:
- Baccalaureate degree AND minimum of 7 years of relevant experience with 5+ years of managerial experience
OR
- Advanced degree AND minimum of 5 years of relevant experience with 5+ years of managerial experience
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Ph
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