We anticipate the application window for this opening will close on - 7 Jul 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

Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That’s the Medtronic Mindset — our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives.

The audit focus will be primarily medical device software, product security, and risk management. We look for leaders who have a clear vision of where we are going and how to get there, bold inclusive thinkers who create new ideas and bring our best solutions forward to benefit our patients, business partners, and customers.
 

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

• Must have experience and knowledge working with regulated medical devices and cybersecurity requirements.

• Manage and oversee internal audit activities, which may include conducting and/or overseeing audits, investigations, and/or interviews; and preparing corresponding reports and documents.

• Coordinate and/or complete internal assessments and/or audits in accordance with regulatory standards, which may include US and/or international regulatory agencies/authorities.

• Interpret and implement applicable regulations as they apply to products, processes, practices, and procedures.

• May counsel stakeholders about these requirements as necessary.

• Ensure compliance with internal and external regulatory agencies, which may include investigating and resolving compliance violations, questions, or concerns.

• Analyze audit data and present findings to management and/or regulatory bodies in support of Corrective Action Plans, which may include coaching business partners on compliance gaps, data, and/or resulting corrective actions.

• Own development of training and awareness programs for SaMD, SiMD, and product security designed to increase auditor awareness and knowledge of requirements.

• Remain informed on Regulatory requirements for Software and Product Security to identify gaps in medical device software.

• Provide detailed functional knowledge and maintain insight to current industry best practices and how they can be applied to Medtronic.

• Explore new tools and techniques to recommend for other team members to audit product security.

• Identify opportunities for product security enhancement.

• Possess understanding of Software Bill of Material (SBOM) development and maintenance for the purposes of vulnerability monitoring.

• Possess an understanding of scoring methodologies for security threats like the common vulnerability scoring (CVSS) and apply appropriately.

• Document and communicate recommended security controls and deficiencies.

• Provide detailed functional knowledge and maintain insight to current industry best practices and how they can be applied to Medtronic.

• Contribute to company standards and policies related to product security risks.

• Enable strong partnerships across the organization to drive best-in-class product security mechanisms.

• Analyze complex issues and significantly improve, change, or adapt existing methods.

• Show creativity and innovation in all aspects of your responsibilities.

• Expected travel: 20-25%

Onsite

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. 

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile. 

• Bachelor's degree with 7+ years of work experience in Quality or regulated industry OR Advanced degree with 5+ years of work experience in Quality or regulated industry

Nice to Have

• Security Certifications (i.e., CISSP, CEH, CISA, CISM, Security+, GSEC, OSCP, etc.)

• Firsthand experience assessin