Firmware Trace Engineer

Overview

On Site
BASED ON EXPERIENCE
Contract - W2
Contract - Independent
Contract - 6+ mo(s)

Skills

FIRMWARE
EMBEDDED SOFTWARE
EMBEDDED SYSTEMS
MICROCONTROLLER
MCU
C++
RTOS
REAL-TIME
LOW-LEVEL SOFTWARE
ACTIVE IMPLANTABLE
IMPLANTABLE DEVICE
AIMD
REGULATED INDUSTRY
MEDICAL TECHNOLOGY
MEDTECH
IEC62304
62304
IEC 60601
60601
MEDICAL STANDARDS

Job Details

Firmware Trace Engineer

Job Summary: Talent Software Services is in search of a Firmware Trace Engineer for a contract position in Irvine, CA. The opportunity will be six months with a strong chance for a long-term extension

Position Summary:

We are seeking a skilled Firmware Engineer to join the client's Urology team. In this role, you will be part of the evaluation and integration of firmware on Axonics Urology medical device technologies. As a technical hands-on contributor, you will focus primarily on tracing software/firmware requirements from design inputs to design outputs, ensuring compliance with medical device regulations.

Primary Responsibilities/Accountabilities:

  • Be responsible for thoroughly tracing active implantable or external device software/firmware requirements to test evidence, and documenting this trace
  • Identifying and escalating any lack of clear trace evidence
  • Assist in identifying test strategies where needed
  • Collaborate with cross-functional teams, including hardware engineers, systems engineers, quality, regulatory affairs, manufacturing and PMO
  • Contribute to a culture of innovation, continuous improvement, and knowledge sharing within the R&D team.
  • Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Qualifications:
  • This role requires knowledge of medical device firmware design, IEC 62304 and 60601 standards, and attention to detail.
  • B. S or M.S. in Computer Science, Electrical Engineering, Computer Engineering, Software Engineering or related major.
  • B. S with 0 - 2+ years of experience in software development, ideally in embedded or application software for medical devices.
  • Strong technical writing skills
  • Sound knowledge of software engineering principles and practices.
  • Strong time management and communication skills.

Preferred:
  • Experience at a medical device manufacturer
  • Experience in active implantable medical devices
  • Working knowledge of IEC 60601 and/or 62304
  • Experience in Cognition Cockpit

If this job is a match for your background, we would be honoured to receive your application!

Providing consulting opportunities to TALENTed people since 1987, we offer a host of opportunities, including contract, contract to hire, and permanent placement. Let's talk!

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About Talent Software Services, Inc