Quality Systems Engineer

Team Description:

Join the Quality Systems Team, where our mission is to ensure compliance with applicable regulatory standards by designing scalable, efficient, and automation-driven systems. We focus on embedding compliance directly into engineering workflows rather than treating it as a manual or reactive function.

We are a team of industry-experienced professionals who apply systems thinking and creative problem-solving to build a durable compliance infrastructure that supports rapid development. Our vision is to establish internal design and quality systems that exceed FDA expectations while enabling fast iteration and deployment of complex, safety-critical software products.

Job Description and Responsibilities:

As a Quality Systems Engineer (dedicated towards Design Controls), your primary responsibility will be to design, implement, and continuously improve software-focused design control systems with regulatory compliance embedded into their architecture.

You will build systems that eliminate ambiguity, reduce manual effort, and enable rapid and reliable development of regulated medical device software. These systems will support the full software lifecycle, from requirements definition through verification, validation, risk management, and release.

You will continuously optimize these systems to improve speed, traceability, and audit readiness while supporting aggressive development timelines and frequent design changes. Your responsibilities include, but are not limited to:

• Design and implement scalable software design controls systems aligned with IEC 62304 and FDA design control requirements (21 CFR 820.30)

• Develop and maintain end-to-end traceability frameworks linking:

  • User needs
  • Software requirements
  • Risk controls
  • Design outputs (code, architecture)
  • Verification and validation evidence

• Integrate software risk management into design controls, ensuring alignment with ISO 14971 principles

• Build change control mechanisms capable of supporting:

  • Rapid iteration
  • Parallel development
  • Same-day deployment

• Partner closely with software engineering teams to embed:

  • Compliance with CI/CD pipelines
  • Automated evidence generation
  • Controlled release processes

• Own subsets of the Quality System related to software design controls, including but not limited to:

  • Software Design Control processes
  • Software Risk Management
  • Software Change Control
  • Software Verification & Validation traceability

Required Qualifications:

• Bachelor’s degree in Electrical Engineering, Computer Science, or a related technical field
• Demonstrated 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
  • Software requirements management
  • Proficiency in basic scripting, automation, or querying (e.g., Python, SQL, or equivalent)

• Excellent written and verbal communication skills

• Strong problem-solving mindset with the ability to think in systems rather than silos

Preferred Qualifications:

• Familiarity with IEC 62304 (Medical Device Software Lifecycle Processes)
• Familiarity with FDA Design Controls (21 CFR 820.30)
• Familiarity with Design Risk Management (ISO 14971 principles)
• 1–3 years of experience in:
  • Design Controls
  • Software Quality
  • Regulated software development