We anticipate the application window for this opening will close on - 30 Jan 2026

 

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

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’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

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

• Lead the development and implementation of a comprehensive post-market surveillance trending program to proactively identify and address product quality and safety issues.

• Design and optimize processes for collecting, analyzing, and reporting post-market data, including complaints, adverse events, and product returns.

• Collaborate with cross-functional teams (Regulatory, R&D, Clinical, etc.) to ensure integration of post-market data into product risk management and continuous improvement initiatives.

• Develop and maintain procedures for tagging complaint codes to Hazard Analysis line items, ensuring accurate linkage between real-world events and risk assessments.

• Oversee updates to risk management files, including Failure Mode and Effects Analysis (FMEA) and Hazard Analysis, based on trending data and complaint code mapping.

• Provide training and guidance to quality and engineering teams on post-market surveillance best practices and complaint code mapping methodologies.

• Prepare and present trending analyses, risk updates, and regulatory reports to internal and external stakeholders.

• Ensure compliance with global regulations and standards (e.g., FDA 21 CFR 820, ISO 13485, EU MDR) related to post-market surveillance and risk management.

• Drive continuous improvement of post-market surveillance processes and tools to enhance product safety and patient outcomes.

Must Have: Minimum Requirements

• Baccalaureate degree 

• Minimum of 10 years of relevant experience OR Master's degree with a minimum of 8 years relevant experience OR PhD with 6 years relevant experience.

 

Nice to Have

• Experience leading post-market surveillance programs in the medical device industry

• Proven ability to drive process improvements and in developing and implementing systems for trending, analyzing, and reporting product quality data

• Knowledge of risk management processes including FMEA and Hazard Analysis

• Strong understanding of global regulatory requirements (FDA 21 CFR 820, ISO 13485, EU MDR)

• Strong analytical skills with the ability to interpret complex data and identify trends

• Effective communicator

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 Physical requirements that may be specific to each role.

Benefits & Compensation
 

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.
 

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