We anticipate the application window for this opening will close on - 19 Dec 2025

 

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

Responsibilities may include the following and other duties may be assigned.
• Serves as Subject Matter Expert for Risk Management across the Post-Market space for their assigned product families
• Accountable for and owns the Risk Management Files for assigned product families within the Robotic Surgical Technologies business.
• Maintains Risk Management Files for assigned product families
• Conducts product Risk Analysis (PHA, RAC, SSRCI/System & Use FMEAs) in compliance with ISO14971
• Evaluates product Risk Management Files against field data to ensure accuracy and correctness of predicted risks; validating pre-market Benefit Risk Analysis and updating the Risk Management Files (RMF) as necessitated
• Initiates and manages Product Hold Orders (PHOs) based upon production and field issues, working with cross-functional teams to develop comprehensive and evidence-based disposition plans
• Initiates and drives Post-Market Issue Evaluations (PMIE) and Health Risk Assessments (HRA) to closure based upon production and field issues, taking into consideration inputs from cross-functional teams
• Initiates and serves as owner/lead for Field Corrective Actions (FCAs) based upon HRA decision working alongside Enterprise FCA team
• Supports post-market regulatory body and competent authority engagements, including but not exclusive to:
o Post-Market Surveillance Report (PMSR), Periodic Safety Update Report (PSUR), Clinical Evaluation Report (CER), Summary of Safety and Clinical Performance (SSCP), Clinical Evaluation Plan (CEP), and Requests For Additional Information (RFAI)
• Reviews and endorses Production Post-Production Risk Assessments (PPPRAs) for Change Development Projects (CDPs), as Risk Management SME
• Consults on New Product Development programs during the Product Transfer to ensure Risk Management Files readiness for post-market. Including review of Risk Management Report (RMR) and Post-Market Surveillance Plan (PMSP).
• Supports and collaborates with Post-Market Vigilance team to investigate complaints into potential adverse trends and aids in the early signal detection of field issues

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

• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.

DIFFERENTIATING FACTORS

Autonomy: Recognized expert, managing large projects or processes. Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager. Coaches, reviews and delegates work to lower level specialists.

Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results. May manage large projects or processes that span outside of immediate job area.

Innovation and Complexity: Problems