Senior Design Quality Engineer

About the Role

Circadia Health is looking for a Senior Design Quality Engineer to establish and lead our quality engineering processes from the ground up. In this role, you will build, implement, and scale our Quality Management System (QMS) in alignment with ISO 13485 and FDA QMSR. You will take full ownership of design controls across the product lifecycle, establish robust complaint handling and CAPA workflows, and lead post-market surveillance activities. This role requires a hands-on, startup-savvy engineer who thrives in fast-paced environments.

Responsibilities

QMS Building & Implementation

• QMS Architecture: Lead the design, implementation, and roll-out of an ISO 13485-compliant Quality Management System.
• Process Creation: Establish and standardize core quality procedures, including document control, change management, CAPA, nonconformance, and audit readiness.
• Compliance Standards: Ensure organizational alignment with ISO 13485 and prepare the company for FDA Inspections/Notified Body audits.

Post-Market Surveillance, Complaints & CAPA

• Complaint Handling: Establish and execute end-to-end complaint handling processes, root-cause investigations, and medical device reporting (MDR) evaluations.
• CAPA Leadership: Drive the CAPA and Nonconformance (NC) processes, performing thorough root-cause analyses and implementing corrective/preventive actions.
• Post-Market Surveillance (PMS): Design and maintain the Post-Market Surveillance (PMS) system, generating PMS reports, clinical evaluation updates, and data trending summaries.

Design Controls & Product Development Support

• Support execution and maintenance of design control activities across the product lifecycle.
• Maintain Design History File (DHF) documentation for Circadia products.
• Assist with preparation and review of:
• Design inputs and outputs
• Risk management documentation
• Verification and validation documentation
• Design review records
• Track design control deliverables and coordinate documentation across teams.

Regulatory Submission Support

• Assist in preparation of FDA submission documentation (e.g., 510(k)).
• Support compilation and organization of testing documentation and reports.
• Track submission deliverables and supporting evidence.

Cross-Functional Collaboration

• Coordinate with R&D, Engineering, Customer Success, Ops and Clinical teams to collect documentation and evidence.
• Support human factors validation and cybersecurity testing coordination.
• Assist with third-party testing documentation collection.

Qualifications

• Education: Bachelor’s degree in Biomedical Engineering, Software Engineering, Mechanical Engineering, or a related technical field.

• Senior-Level Expertise: 5+ years of design quality engineering experience within the medical device or digital health industry.

• Startup Track Record: Proven experience in a fast-paced environment where you built processes from scratch rather than executing existing ones, and are comfortable owning ambiguous, evolving work.

• QMS Implementation: Direct experience building and implementing an ISO 13485 QMS

• Subject Matter Ownership: Deep, hands-on proficiency in Design Controls, Risk Management (ISO 14971), CAPA management, Complaint Handling, and Post-Market Surveillance (PMS).

Nice to Have

• QMSR Familiarity: Direct experience or working knowledge of the FDA’s updated Quality Management System Regulation (QMSR).

• Digital Health / Hardware + Software: Experience with Software as a Medical Device (SaMD) and/or software in a medical device (SiMD), firmware/hardware integration, human factors validation, and cybersecurity.

• Regulatory Submissions: Direct involvement in successful FDA submissions or European CE mark technical files.

• Certifications: ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or Six Sigma Green/Black Belt.