Software Engineer

Software Engineer

📍
*[Location | Remote]*

-Contract role with 6+ months initial duration

Role Summary

We are seeking a
Software Engineer with medical device design controls expertise
to support
design controls remediation
activities for device software. This role is focused on
software‑specific gap assessment and remediation
across
Design Inputs, Design Outputs, Verification & Validation (V&V), and Risk Management
, ensuring compliance with
FDA 21 CFR 820
and
IEC 62304
software lifecycle requirements.

This position is ideal for engineers experienced in software documentation remediation, audit readiness, and legacy or in‑flight medical device programs.

Key Responsibilities

- Perform
software design controls gap assessments
for requirements, architecture, and detailed design documentation
- Remediate
software Design Inputs and Design Outputs
to align with IEC 62304 and FDA expectations
- Support
software risk analysis
(e.g., hazard analysis, SOUP assessments) and ensure alignment with the overall
Risk Management File (ISO 14971)
- Develop, update, and execute
unit‑level and integration verification
protocols, reports, and
traceability matrices
- Identify
software cybersecurity
and
usability/human factors
gaps and recommend risk‑based mitigations
- Ensure
software lifecycle documentation
supports
Design Transfer readiness
and regulatory inspection preparedness
- Partner cross‑functionally with Quality, Systems, Cybersecurity, and Human Factors teams

Required Qualifications

- Bachelor’s degree or higher in
Software Engineering, Computer Science
, or related field
- Medical device software development experience under
IEC 62304
and
21 CFR 820
- Strong experience with
software design controls
, requirements management, and configuration management
- Hands‑on experience with
software remediation or gap assessment projects
(legacy devices, audits, acquisitions, or DHF updates)
- Familiarity with
FDA cybersecurity guidance
, threat modeling, and software risk mitigation
- Exposure to
usability engineering / human factors
as applied to software‑driven medical devices

Why Join Us

• Contribute to meaningful remediation work that directly impacts patient safety and regulatory success.
• Collaborate with experienced quality, clinical, and engineering professionals.
• Flexible work arrangements depending on location and engagement needs.