Sr. Product Security Engineer - Post Market Surveillance
About The Position
The Neuromodulation and Pelvic Health R&D organizations, bring together a large set of Medtronic’s Neurosciences therapies and their project teams to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. These operating units offer devices and therapies to treat chronic pain, movement disorders, overactive bladder, non-obstructive urinary retention, and much more. The Senior Product Security Engineer – Post Market Surveillance leads cybersecurity activities for fielded medical devices and supporting systems. The role owns vulnerability surveillance, field security event assessment, security impact and risk analysis, post-market compliance, security operations support, and issue disposition through closure.
Requirements
- Bachelor’s degree in related field with 4 years of relevant experience OR masters degree in related field with 2 years of relevant experience (Computer Engineering, Electrical Engineering, Computer Science, Cybersecurity)
- Extensive experience in product security, cybersecurity, embedded/software systems, or regulated product development.
Nice To Haves
- Experience with vulnerability management, CVSS, threat modeling, SRA, SBOM/SCA, incident analysis, and medical-device cybersecurity.
- Understanding of medical device regulations and standards (e.g., FDA pre- and post-market guidance on cybersecurity for medical device manufacturers, ISO 13485, ISO 81001-5-1).
- Strong decision-making capabilities, weighing relative costs and benefits to identify the most appropriate solution.
- High attention to detail with a focus on Good Documentation Practices (GDP).
- Ability to communicate complex, technical information in a creative and engaging way to diverse audiences, orally and in writing.
- Excellent prioritization skills, with an aptitude for breaking down work into manageable parts and assessing priority and time required.
- Demonstrated ability to develop and grow productive, trusting, and open relationships with a wide variety of constituencies.
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Responsibilities
- Monitor and assess vulnerability signals, field complaints, anomalous behavior, and suspected security events affecting released products.
- Determine applicability, exploitability, severity, product impact, and required escalation; coordinate investigation, remediation, and disposition.
- Partner with Risk Management and Systems Engineering to update Security Risk Analysis, threat models, hazard analyses, and residual-risk assessments.
- Maintain visibility of security assets across fielded products, including keys, certificates, credentials, trust anchors, and signing infrastructure.
- Support secure provisioning, certificate/key distribution, rotation, revocation, and retirement with manufacturing and operations teams.
- Maintain Defense-in-Depth, Security-by-Design, security requirements, and SBOM expectations throughout the post-market lifecycle.
- Assess evolving FDA, EU MDR, China and other cybersecurity requirements and support fielded-product recertification and remediation.
- Map cybersecurity standards and best practices into internal processes and represent Product Security in standards and technical forums.
- Support HCP/customer security and privacy questionnaires, onboarding, and automation of recurring assurance activities.
- Represent Product Security during regulatory audits, FCA, CAPA, quality reviews, and risk-management boards.
- Support root-cause analysis, corrective actions, effectiveness verification, and closure.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
