Tech Stack

Description

You will design, implement, and improve software-focused design control systems with regulatory compliance embedded into their architecture, supporting the full software lifecycle from requirements through release. You'll work closely with software engineering teams to embed compliance into CI/CD pipelines and automated evidence generation, enabling rapid development of safety-critical medical device software.

Requirements

• Bachelor's degree in Electrical Engineering, Computer Science, or related technical field
• Experience designing or maintaining structured engineering or compliance systems
• Familiarity with software development lifecycles in regulated or safety-critical environments
• Working knowledge of design controls and software requirements management
• Proficiency in basic scripting or automation (Python, SQL, or equivalent)

Responsibilities

• Design and implement scalable software design controls systems aligned with IEC 62304 and FDA 21 CFR 820.30
• Develop end-to-end traceability frameworks linking user needs, software requirements, risk controls, design outputs, and verification evidence
• Integrate software risk management into design controls per ISO 14971 principles
• Build change control mechanisms supporting rapid iteration, parallel development, and same-day deployment
• Own subsets of the Quality System related to software design controls, risk management, and change control