Boston Scientific · 3 weeks ago
Senior Firmware Engineer
Irvine, CA
Contract
Onsite
Senior Level
$82/hr - $82/hr
5+ years expBoston Scientific is a leading company in Class III Active Implantable Medical Devices, and they are seeking a Firmware Test Engineer to support verification and validation activities for embedded firmware. The role involves developing automated and manual test solutions while ensuring compliance with regulatory standards.
Health CareMedicalMedical Device
Hiring Manager
Bill Sunderland
Responsibilities
Develop and execute test plans, protocols, and reports in accordance with IEC 62304 and FDA regulatory requirements
Prepare and perform risk‑based software testing (unit and integration) aligned with IEC 62304, IEC 60601, and other applicable standards
Produce high‑quality test deliverables that meet ISO 14971 expectations for regulatory submissions
Design, implement, and maintain test automation frameworks and tools to support continuous integration and continuous testing
Support development of test infrastructure, including hardware‑in‑the‑loop (HIL) systems and simulation environments
Work with software developers and system engineers to define test requirements and ensure comprehensive test coverage
Participate in design reviews, code reviews, and integration activities
Support test method development for both product firmware and manufacturing process software
Qualification
Required
Bachelor's degree in Computer Science, Software Engineering, Electrical Engineering, or a related field
5+ years of software testing experience in regulated environments (medical device experience strongly preferred)
Hands‑on experience with: C#
Test automation frameworks
CI/CD tools (e.g., Jenkins, Bitbucket, JIRA)
Working knowledge of IEC 62304, IEC 60601, ISO 14971, and V&V processes for Class III medical devices
Proven ability to produce compliant documentation for audits and regulatory submissions
Preferred
Experience testing firmware for Class III active implantable devices
Familiarity with risk‑based testing and traceability tools (e.g., Cognition Cockpit)
Experience supporting product integration projects and collaborating with global teams
Company
Boston Scientific
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
10001+ employees
H1B Sponsorship
Boston Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (114)
2024 (106)
2023 (93)
2022 (140)
2021 (111)
2020 (97)
Funding
Current Stage
Public CompanyTotal Funding
$10.02B2025-02-21Post Ipo Debt· $1.58B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B
Leadership Team
Michael Mahoney
Chairman, President & CEO
Daniel J. Brennan
Chief Financial Officer
Recent News
BioWorld Financial Watch
2025-12-25
2025-12-12
Company data provided by crunchbase