Sr. Product Security Engineer; Medical Devices

Position: Sr. Product Security Engineer (Medical Devices
Role:
Sr. Product Security Engineer (Medical Devices)

Location:

Burlington, MA (Hybrid - Onsite M/W/F required)

Employment Type:

Full-Time

Salary: $140,

About the Role

We are seeking a Senior Product Security Engineer to join our team in Burlington, MA. This is a highly technical, hands-on role focused on securing embedded medical devices across the full product lifecycle. You will play a key role in designing and implementing security architecture, working closely with firmware, software, and systems engineering teams to ensure products are secure by design and aligned with regulatory expectations.

This position sits within the broader GRC organization but operates as a deeply technical product security function, bridging engineering, security, and compliance.

Key Responsibilities

Design and define security architecture for embedded and connected medical devices

Lead secure-by-design initiatives, including threat modeling and risk mitigation

Develop and review security solutions for authentication, encryption, secure communications, and data protection

Partner with engineering teams to embed security into the product lifecycle.

Product & Embedded Security

Work closely with firmware and software teams to improve security of device components and interfaces

Support OS and platform hardening (Windows/Linux-based systems)

Ensure secure update mechanisms, integrity validation, and secure configurations.

Penetration Testing & Validation

Manage and coordinate third-party penetration testing engagements

Define testing scope, review findings, and drive remediation efforts

Ensure security validation throughout design, development, and pre-market stages.

Vulnerability Management

Lead identification, tracking, and remediation of vulnerabilities across products

Coordinate cross-functional response to security issues and disclosures

Monitor third-party component risks and dependencies.

Process & SOP Development

Develop and implement security processes, standards, and SOPsHelp mature the organization’s product security program

Ensure alignment with regulatory and internal security expectations.

Required Qualifications

7+ years of experience in cybersecurity, product security, or software engineering

Strong experience in medical device security (REQUIRED)

Proven background in security architecture and secure design for embedded or connected systems

Experience working with cross-functional engineering teams (firmware, software, systems)

Hands-on involvement in threat modeling, vulnerability management, and security testing

Experience managing or working with third-party penetration testing vendors.

Qualifications

Experience in regulated environments (FDA, healthcare, or similar)

Knowledge of standards such as ISO 14971, IEC 81001-5-1, NIST, or similar frameworks

Background in embedded systems, IoT, or device-level security

Experience building or improving security processes and SOPs.

What Makes This Role Unique

High-impact role shaping security architecture for real-world medical devices

Opportunity to work at the intersection of engineering, security, and regulatory compliance

Direct influence on product security strategy and implementation

Collaborative, cross-functional environment with strong engineering partnership.

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