Medical Device Security Developer Jobs

1 job found

2d ago

Software Developer V

Bio-Rad Laboratories, Inc. Hercules, CA

Hercules, CA

2d ago

$179k - $247k/yr Full time Senior Engineering Information Security

Apply Now

Job Description

Bio-Rad Laboratories, a leader in clinical diagnostics, is seeking a senior technical leader to own the strategy, governance, and execution of the Product Cybersecurity Program and PSIRT across the Clinical Diagnostics portfolio. This onsite role in Hercules, California, anchors the company’s efforts to align with FDA and global regulatory expectations while guiding product teams through secure design, development, and maintenance throughout the product lifecycle. As the Software Developer V, you will serve as the technical authority on product cybersecurity, coordinating cross-functional collaboration and external engagements to uphold a security-first posture.

Responsibilities

Own and advance the Product Cybersecurity Program, including PSIRT governance, operating model, decision rights, and escalation pathways.
Align with FDA medical device cybersecurity expectations for premarket and post-market vulnerability management, coordinated disclosure, and incident response.
Define and maintain a cybersecurity framework aligned to NIST CSF 2.0, ISO 81001‑5‑1, ISO/IEC TS 27110, and ISO/IEC 27032, ensuring integration with Global IT security practices.
Embed product cybersecurity requirements into the Global Quality Management System (QMS), including Design Controls, risk management, and change management.
Lead the cross-functional Cybersecurity Core Team, sustaining engagement across R&D, Software, Systems, QA/RA, Global Supply Chain (Manufacturing and Procurement), and Global Information Security.
Provide clear expectations, guidance, and oversight to product teams for secure design, development, and maintenance, without direct development ownership.
Ensure cybersecurity considerations are integrated throughout the product lifecycle, from concept and design through post‑market support.
Serve as the single point of accountability for product cybersecurity intake, triage, and prioritization.
Oversee end‑to‑end vulnerability management, including risk assessment, remediation planning, regulatory timelines, and customer deployment.
Lead technical coordination for cybersecurity incident investigations, containment, and remediation, ensuring timely response to high‑severity issues.
Guide product teams on mitigations, patches, and workarounds to meet security and regulatory expectations.
Ensure cybersecurity incidents and disclosures comply with FDA, international regulatory, and internal quality requirements.
Oversee the development and approval of security advisories, customer notifications, and regulatory communications.
Act as the technical authority in engagements with external security researchers, customers, regulators, and industry groups.
Drive cybersecurity awareness and training for R&D, Support, and Quality teams to reinforce a security‑first culture.
Define, track, and report program‑level cybersecurity and PSIRT performance metrics to leadership.
Continuously improve program effectiveness based on metrics, lessons learned, and evolving regulatory expectations.

Requirements

Bachelor’s degree in Computer Science, Information Security, Engineering or a related field.
7+ years of experience in cybersecurity, including architecture design in a regulated environment, preferably FDA, healthcare, or medical devices.
System thinker with deep expertise in medical device cybersecurity, including FDA premarket and post‑market requirements.
Expert knowledge of NIST CSF 2.0, ISO 81001‑5‑1, ISO/IEC TS 27110, and ISO/IEC 27032.
Proven ability to lead cross‑functional programs in complex, matrixed organizations.
Strong technical judgment, communication skills, and executive presence.
Demonstrated ability to build, mature, and scale cybersecurity programs across organizations.
Preferred: Master’s degree in a technical field.
Certifications: CISSP, CSSLP, CISM, or equivalent.
Experience with cloud-based systems, IoT security, or medical device security.

Technologies

NIST CSF 2.0
ISO 81001‑5‑1
ISO/IEC TS 27110
ISO/IEC 27032

Benefits

Competitive medical plans for you and your family
Free HSA funds
New fertility offering with stipend
Group life and disability
Paid parental leave
401k plus profit sharing
Employee stock purchase program
New upgraded and streamlined mental health platform
Extensive learning and development opportunities
Education benefits
Student debt relief program
Pet insurance
Wellness challenges and support
Paid time off
Employee Resource Groups (ERG’s)

View full job page →

Get Medical Device Security Developer Jobs alerts

New Medical Device Security Developer Jobs, daily.