Senior Design Quality Engineer

This is a fully remote position, open to applicants in United States.

📋 Description

• Collaborate with engineering and data science throughout the entire software lifecycle, which encompasses requirements gathering, architecture review, software risk analysis, verification and validation, traceability, and ensuring release readiness.

• Uphold the design history file and risk management file in line with IEC 62304, ISO 14971, and 21 CFR 820 (QMSR) design controls.

• Evaluate software and model modifications for regulatory implications and ascertain if a letter-to-file or new submission is necessary.

• Propel changes through the quality management system.

• Maintain the risk file and assist with post-market performance monitoring of deployed algorithms.

• Aid in the complaint intake, triage, investigation, and resolution processes.

• Generate MDR reportability assessments as per 21 CFR 803 for review and approval.

• Analyze trends in complaints and field data.

• Lead nonconformance reports and CAPAs in response to emerging patterns.

• Ensure that feedback from implementation and clinical teams is integrated into the quality system.

• Update and manage quality procedures, document control, training records, and compliance evidence.

• Assist in internal audits and prepare inputs for management reviews.

• Oversee supplier controls for EHR, cloud, and subcontractor relationships.

• Contribute to 510(k)s, Q-Submissions, and Predetermined Change Control Plans.

• Address inquiries from the FDA and assist during FDA inspections.

• Stay informed on FDA guidance regarding AI/ML-enabled devices, cybersecurity under Section 524B, and quality system requirements.

• Transform emerging regulatory demands into modifications to procedures and product specifications.

• Integrate compliance within product, engineering, and commercial workflows.

• Convey quality metrics and risk to both technical and non-technical stakeholders, including executives.

• Collaborate directly with engineering, data science, clinical, and implementation teams under the supervision of the Head of Quality and Regulatory.

⛳️ Requirements

• Bachelor’s degree in Computer Science, Systems Engineering, Biomedical Engineering, or a similar technical discipline, or equivalent practical experience.

• A minimum of 5 years in software quality, design quality engineering, or regulatory roles for software medical devices compliant with ISO 13485 and IEC 62304.

• Hands-on experience managing design controls and ISO 14971 risk management files.

• Proficient in handling complaints and making adverse event reportability decisions in accordance with 21 CFR 803 and 21 CFR 820 (QSR or QMSR).

• Background in complaint investigation, trending, and CAPA.

• Proven history of drafting, maintaining, and enhancing QMS procedures, document control, and change management in a regulated software setting.

• Capability to read code, logs, and automated test results for independent software issue investigation.

• Comfortable collaborating with engineers in a cloud-based SaaS environment.

• Familiarity with FDA premarket cybersecurity expectations under Section 524B, including threat modeling, SBOM management, and vulnerability handling.

• Exceptional written communication skills, capable of producing audit-ready records and clearly explaining regulatory concepts to engineers, clinicians, and executives.

• High motivation, a process-improver mindset, rapid learning ability, and effective communication skills.

• Current, unrestricted authorization to work in the United States.

• Preferred: Experience with AI/ML-enabled medical devices, algorithm change control, Predetermined Change Control Plans, model performance monitoring, and FDA AI/ML guidance.

• Preferred: Experience in preparing 510(k)s or Q-Submissions and liaising with FDA reviewers.

• Preferred: Knowledge of EHR-integrated software such as Epic or Oracle Health, SMART on FHIR, or CDS Hooks.

• Preferred: Experience supporting FDA inspections, ISO 13485 certification audits, or customer audits.

• Preferred: Familiarity with eQMS platforms, Jira-based defect tracking, and computerized system validation.

• Preferred: ASQ CQE/CSQE, RAC, or equivalent quality or regulatory certification.

• Must be available to work synchronously from 11 a.m. to 5 p.m. ET (8 a.m. to 2 p.m. PT).

• Visa sponsorship is not available.

🏝️ Benefits

• Comprehensive medical, dental, and vision insurance through Anthem Blue Cross Blue Shield, Guardian, and VSP.

• HSA-eligible medical options.

• Company-funded life insurance, short-term disability, and long-term disability coverage.

• 401(k) retirement plan with company contributions.

• Complimentary mental health support via Spring Health.

• Wellness resources, including pet care benefits.

• Generous paid time off that increases with tenure.

• Paid sick leave.

• Paid holidays.

• Occasional company-wide self-care days.

• Equity opportunities.

• Fully funded annual company retreat.

• Choice of Mac hardware.

• One-time stipend for home office setup.

• Ongoing reimbursement for internet and phone expenses.

• Flexible remote work arrangement.

• Geographic premium eligibility for candidates located in certain high-cost cities.