About the Role
Title: Principal Software and Product Security Compliance Specialist Audit Support (Remote)
Locations: Minneapolis, Minnesota, United States of America
Full Time
Job Description:
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
CAREERS THAT CHANGE LIVES
In this exciting role as a Principal Software and Product Security Compliance/Audit Specialist you will have responsibility to plan, lead, conduct and report on internal audits of Medtronic facilities worldwide to determine the state of compliance to appropriate regulations and standards, corporate policies, and expectations. Additionally responsible for training and education of internal audit organization to SaMD, SiMD, and product security requirements.
A Day in the Life
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.
We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. Our unwavering commitment to inclusion, diversity, and equity (ID&E) means zero barriers to opportunity within Medtronic and a culture where all employees belong, are respected, and feel valued for who they are and the life experiences they contribute. We know equity starts beyond our workplace, and we must play a role in addressing systemic inequities in our communications if we hope to have long-term sustainable impact.
As a Prin Software and Product Security Compliance Specialist:
- Must have experience and knowledge working with regulated medical devices and cybersecurity requirements.
- Manages and oversees internal audit activities, which may include conducting and/or overseeing audits, investigations, and/or interviews; and preparing corresponding reports and documents.
- Coordinates and/or completes internal assessments and/or audits in accordance with regulatory standards, which may include US and/or international regulatory agencies/authorities.
- Interprets and implements applicable regulations as they apply to products, processes, practices, and procedures.
- May counsel stakeholders about these requirements as necessary.
- Ensures compliance with internal and external regulatory agencies, which may include investigating and resolving compliance violations, questions, or concerns.
- Analyzes audit data and presents 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.
- Analyzes complex issues and significantly improves, changes, or adapts existing methods.
- Show creativity and innovation in all aspects of your responsibilities
- Expected travel: 20-25%
- Role may be remote, hybrid, or in office.
QUALIFICATIONS:
- Bachelor’s degree and minimum 4+ years of cybersecurity and/or secure software engineering experience in quality or regulatory industry
- 2+ years of cybersecurity and/or secure software engineering experience in quality or regulatory industry with an Advanced Degree
Nice to Have:
- Security Certifications (i.e., CISSP, CEH, CISA, CISM, Security+, GSEC, OSCP, etc.)
- Firsthand experience assessing the embedded security of regulated or safety critical devices
- Experience in Quality/Compliance and/or Audit with medical device requirements (e.g., MDSAP, EU MDR, ISO 13485)
- Experience with cybersecurity requirements
- TUV; EU MDR / MDCG
- IMDRF’s Principles and Practices for Medical Device Cybersecurity
- ENISA – EU Cybersecurity Act
- European Commission’s Guidance on Cybersecurity of Medical Devices (MDCG)
- United States FDA Pre-Market and Post-Market Guidance
- TIR 57 and TIR 97
- ISO 80001-2 series and 14971
- Experience auditing Quality Systems to global requirements
- Quality System Lead Auditor certified
- Prior FDA or NB auditor experience
- Experience performing hardware and software penetration testing
- Understanding of the security development process and product development process
- Experience in leading small teams
- Knowledge in risk management and assessment methodologies, security frameworks and relevant global regulations
- Strong capability to research and evaluate emerging technologies
- A solid familiarity of threat modeling, vulnerability scanning tools, and common attack routes is essential.
- Demonstrated ability to be flexible and take a proactive approach to managing change
- Experience working in a regulated environment and/or a formal quality system
- Occasional after-hours availability to accommodate different regional and global partners.
- A solid familiarity of threat modeling, vulnerability scanning tools, and common attack routes is essential.
- Medical device engineering experience
- Strong technical and troubleshooting skills.
- Strong capability to research and evaluate emerging technologies
- Preference is given to those with relevant product security or engineering experience.
- Strong in interpersonal communication and demonstrate a collaborative work style.
- Comfortable working in an ambiguous environment.
- Innovative thinker: ability to think outside of the current norms and processes
- Independent self-starter
- Strong communication and collaboration skills
- Solid writing and presentation skills
- Interest in novel applications of technology