Software Design Control Engineer

Job Description

We are seeking a Software Design Control Engineer to drive end-to-end documentation and process rigor across our Class III medical device software products, supporting both clinical trials and commercialization. This role sits at the intersection of software engineering, quality systems, and regulatory compliance. You will bring medical device best practices across quality and engineering to ensure our software is safe, effective, compliant, and ready for market.

Role Responsibilities

• Embedded Design Controls: Work alongside software engineers to author, review, and maintain comprehensive design control documentation, including Software Requirements Specifications, Architecture & Design Documents, and Traceability Matrices.
• Lifecycle Compliance: Ensure software development processes align with IEC 62304 (Medical Device Software Lifecycle), ISO 13485, and FDA 21 CFR Part 820 regulations.
• Risk Management: Author and maintain software risk management files, including Software FMEAs per ISO 14971.
• V&V Partnership: Produce software verification and validation (V&V) protocols and reports in coordination with the engineering and test teams to ensure full traceability.
• Regulatory Submission Prep: Compile and organize necessary software technical documentation for regulatory submissions.
• Post-Market Support: Maintain and update software documentation for post-market surveillance, CAPAs, and software updates.

Qualifications

Required Qualifications

• Experience: 5+ years of experience in the medical device industry, specifically working with software-driven or connected medical devices (Class II or Class III).
• Technical Background: A Bachelor’s degree in Computer Science, Biomedical Engineering, Software Engineering, or a related field, or equivalent practical engineering experience.
• Technical Writing: Demonstrated experience writing, reviewing, and managing formal medical device software documentation (Design History Files, Traceability Matrices).
• Product Lifecycle: Proven track record of taking a medical device software product through a successful FDA clearance/approval process and subsequent launch.

Preferred Qualifications

• Standards Expertise: Deep familiarity with IEC 62304, ISO 14971, and FDA Software Validation Guidelines.
• Tooling: Experience with modern software development workflows (e.g. Git, Jira) and quality system tools (e.g. Greenlight Guru, Arena, Matrix Requirements, or Jama).
• Post-Market Management: Experience maintaining medical device software post-launch, including managing software changes and compliance updates.