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Quality Design Controls Software Engineer - Actalent
Software Engineer
Lead software design control activities for medical device software, creating and maintaining evidence, procedures, and templates within a regulated QMS environment.
About the role
Key Responsibilities
- Develop, own, and continuously improve software Design & Development procedures, templates, and design plans.
- Generate and maintain design control evidence for new releases and changes, ensuring traceability from requirements to verification.
- Coordinate with cross‑functional teams to integrate design control activities into the existing QMS change control process.
- Conduct verification and validation activities, including risk assessments, to meet FDA and ISO 13485 requirements.
- Prepare and review technical documentation, such as design history files, specifications, and test reports.
Requirements
- Bachelor’s degree in Engineering, Computer Science, or related field with 3+ years of experience in software design control for regulated medical devices.
- Strong knowledge of QMS standards (FDA 21 CFR Part 820, ISO 13485) and design control lifecycle.
- Hands‑on experience with verification & validation, risk management, and documentation practices.
- Excellent communication and collaboration skills to work with multidisciplinary teams.
- Detail‑oriented mindset with the ability to manage multiple design control deliverables simultaneously.
Skills
figmaui designux research