Senior Design Quality Engineer — AI Medical Devices (Remote)

Openkrill; United States; Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Remote work

Health coverage through medical plan

Job summary

Bayesian Health is seeking a Senior Design Quality Engineer to safeguard quality across the full software lifecycle. You will work with engineering, data science, clinical, and implementation teams to ensure compliance with IEC 62304, ISO 14971, and 21 CFR 820 while we scale our FDA-cleared AI clinical decision support platform.

You’ll lead design controls, change management, and post-market activities, translating regulatory guidance into concrete procedures and product requirements.

Qualifications

• BS in CS/engineering or equivalent experience, 5+ years in regulated software quality for medical devices
• Proven track record with ISO 13485, IEC 62304, and 21 CFR 820/803 processes
• Experience handling complaint investigations and CAPAs in a regulated environment
• Ability to read code, logs, and test evidence to investigate issues with engineers
• Knowledge of FDA cybersecurity expectations under Section 524B

Responsibilities

• Engineer quality into software during development and design controls
• Oversee post-market surveillance and change control lifecycle
• Support regulatory submissions (510(k)/Q-Submissions) and MDR assessments
• Maintain and improve QMS procedures, document control, and supplier controls
• Collaborate with cross-functional teams (engineering, clinical, implementation) to ensure quality metrics are clear and actionable
• Prepare audit-ready records and support FDA inspections

Skills

Regulatory compliance

Software quality

QMS procedures

Code readability

FDA cybersecurity

Written communication

US work authorization

Education

BS in Computer Science / Systems Engineering / Biomedical Engineering or related field

Tools

Jira

eQMS platforms

Job description

Bayesian Health is seeking a Senior Design Quality Engineer to safeguard quality across the full software lifecycle. You will work with engineering, data science, clinical, and implementation teams to ensure compliance with IEC 62304, ISO 14971, and 21 CFR 820 while we scale our FDA-cleared AI clinical decision support platform.

You’ll lead design controls, change management, and post-market activities, translating regulatory guidance into concrete procedures and product requirements.