C++ Embedded Software Development with Medical Device

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C++ Embedded Software Development with Medical Device,

REMOTE

Long Term Contract

In need for a C++ firmware developer with IEC62304 experience.

C++ Embedded Software Development with Medical Device experience.

The person takes over remaining software documentation and verification work from a departing R&D lead, so they need to be productive within days.

Must-have skills

  • Software development background: able to read and reason about system and software architecture, including error-handling design and expected behavior.
  • IEC 62304: hands-on experience with the medical device software lifecycle and its deliverables, including software safety classification.
  • Risk management: experience closing open risk actions and linking risks to requirements and verification (ISO 14971).
  • Requirements engineering: decomposing requirements and building end-to-end traceability from requirement to design to verification evidence.
  • Software lifecycle documentation: fluent in how the SRS, SHDD (hardware/software design descriptions), ICD (interface control), and architecture documents relate, and able to reconcile discrepancies across them.
  • Verification: identifying and closing verification gaps, maintaining a verification gap matrix, and assessing whether test evidence supports each requirement.

Nice to have

  • Prior EU MDR technical file or notified body remediation experience
  • Embedded or firmware experience on a Class II medical device
  • Comfort owning a visible action tracker and reporting status to regulatory and QA stakeholders

What they'll do in the first weeks

  • Reconcile architecture, SHDDs, ICD, requirements, and verification evidence
  • Complete traceability for specific open requirements and close verification gaps
  • Correct inconsistencies across the software documentation set
  • Close open risk management and safety-classification items

Experience:

  • IEC62304 : 1 year (Required)
  • Medical Device: 1 year (Required)
  • ISO 14001: 1 year (Required)

Work Location: Remote

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