Overview
Skills
Job Details
Job Title: Firmware Engineer - II
Duration: 6 Months (Possible Extension)
Work Arrangement: Remote (US-based only)
About the Role
Seeking a skilled Firmware Engineer to support the evaluation and integration of firmware used in Urology medical device technologies. This is a technical, hands-on engineering role centered around tracing software/firmware requirements from design inputs to design outputs to ensure full compliance with medical device regulatory standards.
This role requires expertise in medical device firmware, along with working knowledge of IEC 62304 and IEC 60601 standards. Strong attention to detail and documentation accuracy are essential.
Key Responsibilities
Perform thorough tracing of active implantable or external device software/firmware requirements to corresponding test evidence.
Document requirement traceability and escalate any missing or unclear trace evidence.
Assist in identifying appropriate test strategies where needed.
Collaborate with cross-functional teams, including:
- Hardware Engineering
- Systems Engineering
- Quality Assurance
- Regulatory Affairs
- Manufacturing
- Project Management (PMO)
Contribute to a culture of innovation, continuous improvement, and knowledge sharing within the R&D team.
Quality Systems Responsibilities
- Maintain full compliance with all quality system requirements.
- Build Quality into all work and deliverables.
Required Experience
- B.S. or M.S. in Computer Science, Electrical Engineering, Computer Engineering, Software Engineering, or related field.
- 0 2+ years of experience in software development, ideally involving embedded or application software for medical devices.
- Strong technical writing and documentation skills.
- Solid understanding of software engineering principles and practices.
- Excellent time management and communication skills.
Preferred Qualifications
- Experience working at medical device manufacturer.
- Experience with active implantable medical devices.
- Working knowledge of IEC 60601 and/or IEC 62304 standards.
- Experience with Cognition Cockpit or similar requirements management systems.