Software Developer V

Tri-Valley Career Center; Hercules (CA); On-site; USD 179,400 - 246,600; Full time

Benefits offered by this job

Medical plans

Employee stock purchase program

Parental leave

Education benefits

Job summary

Bio‑Rad is seeking a Technical Leader for its Product Cybersecurity Program and PSIRT to advance cybersecurity across the Clinical Diagnostics portfolio. You will own strategy, governance, and execution, ensuring FDA/regulatory alignment and driving program maturity across lifecycle stages.

The role requires leadership of cross‑functional teams, deep domain expertise in medical device cybersecurity, and strong executive communication. Location is Hercules, CA or Irvine, CA with on‑site work.

Qualifications

• Bachelor’s degree required in CS/InfoSec/Engineering or related field.
• 7+ years of cybersecurity experience including architecture design in regulated environments (FDA/healthcare/medical devices)
• Deep expertise in medical device cybersecurity including FDA premarket and post‑market requirements
• Proven knowledge of NIST CSF 2.0, ISO 81001‑5‑1, ISO/IEC TS 27110, ISO/IEC 27032
• Strong ability to lead cross‑functional programs in complex organizations
• Certifications: CISSP, CSSLP, CISM or equivalent

Responsibilities

• Own and evolve the Product Cybersecurity Program including PSIRT governance and escalation paths
• Align with FDA cybersecurity expectations for vulnerability management, disclosure, and incident response
• Define cybersecurity framework aligned to NIST/ISO and integrate with Global IT security
• Embed cybersecurity requirements into the Global QMS with Design Controls and risk management
• Lead cross‑functional Cybersecurity Core Team across R&D, Software, QA/RA, Supply Chain, and InfoSec
• Oversee end‑to‑end vulnerability management and incident investigations
• Guide product teams on mitigations, patches, and regulatory compliance

Skills

Cybersecurity leadership

Regulated environment design

NIST CSF 2.0

ISO standards knowledge

Cross-functional coordination

Executive presence

Education

Bachelor’s degree in Computer Science, Information Security, Engineering or related field

Master’s degree (preferred)

Tools

Cloud-based systems

IoT security

Medical device security

Job description

The Technical Leader for the Product Cybersecurity Program and Product Security Incident Response Team (PSIRT) provides leadership for medical device cybersecurity across Bio‑Rad’s Clinical Diagnostics portfolio. This role owns the strategy, governance, and execution of the product cybersecurity program, ensuring compliance with FDA requirements and global standards while driving program maturity across the organization and product lifecycle. This position serves as the authoritative technical leader for product cybersecurity, accountable for vulnerability management, incident response, regulatory alignment, and cross‑functional coordination. The role operates at the program level, enabling and guiding product teams rather than replacing their functional ownership.

How You’ll Make an Impact

Program Leadership & Governance

• Own and evolve the Product Cybersecurity Program, including PSIRT governance, operating model, decision authority, and escalation paths.
• Establish and maintain alignment with FDA medical device cybersecurity expectations, including premarket and post‑market requirements for vulnerability management, coordinated disclosure, and incident response.
• Define and maintain the cybersecurity framework aligned to NIST CSF 2.0, ISO 81001‑5‑1, ISO/IEC TS 27110, and ISO/IEC 27032, and ensure 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.

Cross‑Functional Enablement

• Lead the cross‑functional Cybersecurity Core Team, ensuring sustained engagement and prioritization 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 assuming direct development ownership.
• Ensure cybersecurity considerations are integrated throughout the product lifecycle, from concept and design through post‑market support.

Vulnerability & Incident Management (PSIRT)

• 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 and effective response to high‑severity issues.
• Guide product teams on mitigations, patches, and workarounds to ensure security and regulatory expectations are met.

Regulatory & External Communication

• 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.

Training, Metrics & Continuous Improvement

• 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.

What You Bring

• 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).
• A system thinker with deep expertise in medical device cybersecurity, including FDA premarket and post‑market cybersecurity 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.

Location

This position must be based in Hercules, CA or Irvine, CA and requires the employee to be located within commuting distance of the office.

Total Rewards Package

Bio‑Rad offers a comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. The program includes competitive medical plans, free HSA funds, fertility assistance, group life and disability, paid parental leave, 401(k) plus profit sharing, an employee stock purchase program, an enhanced mental health platform, learning and development opportunities, education benefits, student debt relief, pet insurance, wellness challenges, paid time off, Employee Resource Groups, and more.

Compensation

The estimated base salary range for this position is $179,400 - $246,600. Actual compensation will be provided at the time of offer and may include a variable annual bonus dependent on achievement of individual objectives and company performance.

Who We Are

For 70 years, Bio‑Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high‑quality research and clinical diagnostic products.

EEO Statement

Bio‑Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply.