Prin Quality Engineer

We anticipate the application window for this opening will close on - 31 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.

We are seeking a highly skilled Risk Management Expert with deep knowledge of ISO 14971 to lead risk management strategy for our medical device products (Capital and disposable). This role is pivotal in ensuring product safety, regulatory compliance, and effective risk mitigation throughout the product lifecycle.

• Creating and managing risk management plans and reports, as well as conducting regular risk reviews.
• Performing thorough hazard analyses to identify potential risks and implement effective mitigation measures.
• Leading Failure Modes and Effects Analyses (FMEAs) in collaboration with project teams to systematically evaluate potential failure modes and their impacts.
• Analyzing and reviewing product complaints to anticipate and prevent future issues.
• Conducting detailed risk analyses in conjunction with the system engineering team to ensure all potential risks are identified and addressed.
• Implementing and maintaining robust product security measures to protect against potential vulnerabilities.
• Developing and managing post‑market surveillance plans to monitor product performance and safety in the field.
• Maintaining and curating risk logs to ensure accurate and up‑to‑date risk documentation.

• Lead and mentor teams in the development, implementation, and maintenance of quality assurance processes and standards.
• Collaborate with cross‑functional teams, including R&D, manufacturing, NPD and regulatory affairs, to define and implement systems engineering processes that ensure product quality and compliance throughout the product lifecycle.
• Ensure compliance with all relevant regulatory requirements, including FDA, ISO, and other international standards, and participate in regulatory audits and inspections.
• Oversee validation and verification activities, including the development of test plans, protocols, and reports to ensure that products meet specified requirements.
• Ensure thorough and accurate documentation of quality assurance activities, including test results, risk assessments, and compliance reports.

• Education: Bachelor’s degree in Engineering, or a related technical field. Advanced degree preferred.
• Regulatory Knowledge: In‑depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant standards.
• Problem‑Solving: Strong analytical and problem‐solving skills with the ability to conduct thorough root cause analysis.
• Communication: Excellent written and verbal communication skills, with the ability to effectively collaborate with cross‑functional teams and present complex information to stakeholders.
• Leadership: Proven leadership and project management skills with the ability to lead teams and manage multiple projects simultaneously.

• Certifications: Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification is preferred.
• Experience: Experience in Quality Assurance, Engineering, Capital equipment.
• Industry
  
  Experience:
  
  Medical device industry.
• Technical
  
  Skills:
  
  Proficient in quality assurance practices, risk management, and regulatory compliance.

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…