[All remote jobs](https://jobicy.com/jobs.md)[![Bayesian Health logo](https://jobicy.com/data/server-nyc0409/galaxy/mercury/2025/08/f74593d8-221.png)](https://jobicy.com/company/bayesian-health.md)[Bayesian Health](https://jobicy.com/company/bayesian-health.md) # Senior Design Quality Engineer Review the role, location requirements, compensation details, and application process before deciding whether this opportunity fits your next career move. [Apply for this job](#job-application)[View company](https://jobicy.com/company/bayesian-health.md)ShareRemote from[USA](https://jobicy.com/job-region/usa.md)SalaryUSD 142,768–161,901 / yrDepartment[QA & Testing](https://jobicy.com/categories/qa-testing.md)EmploymentFull TimeExperienceSeniorPublished8 Oct 2026Apply before7 Nov 2026Listing views36Application actions1Application toolkit ## Make your next move. Prepare your resume, explore your fit, and draft a cover letter for this opportunity. AI Summary ## The role, at a glance. Bayesian Health is seeking a Senior Design Quality Engineer to own software design quality, post-market surveillance, and quality-system activities for an FDA-cleared AI clinical decision-support platform. The role partners closely with engineering, data science, clinical, implementation, and leadership teams to maintain design controls, risk files, verification evidence, complaint investigations, CAPAs, and release readiness. It also supports FDA-facing activities, including 510(k)s, Q-Submissions, inspection readiness, and regulatory assessment of software and algorithm changes. The ideal candidate has substantial experience with regulated medical-device software, including ISO 13485, IEC 62304, ISO 14971, 21 CFR 803, and 21 CFR 820 requirements. This is a senior, highly cross-functional remote US role requiring independent technical investigation and precise audit-ready communication. ## Role DNA A quick view of the complexity, pace, ownership and collaboration implied by the job description. ### Job Complexity 5/5EasyHard ### Pace & Pressure 5/5RelaxedFast-paced ### Autonomy Level 5/5GuidedFull ownership ### Communication Load 5/5IndependentCollaborative AI insightThis is a demanding senior role because it combines design quality, regulatory strategy, complaint handling, post-market surveillance, and QMS ownership within a small, fast-moving medical AI company. The engineer must independently interpret technical evidence and evolving FDA requirements while ensuring patient-safety and compliance decisions are defensible. ## Salary analysis Estimated compensation compared with the broader US market for similar roles. Estimated job medianMarket rate$152,335US market range$130k–$175k0$193k AI insightThe disclosed annual salary range is $142,768-$161,901 USD, with a midpoint of $152,334.50. This sits within an estimated US market range of $130,000-$175,000 annually for a senior medical-device software design quality engineer with FDA, AI/ML, and post-market regulatory responsibilities; geographic premiums may increase total pay for eligible high-cost locations. ## Core skills Skills and capabilities most closely associated with this opportunity. [Design Quality Engineering](https://jobicy.com/jobs?search_keywords=Design%20Quality%20Engineering.md)[Medical Device Software](https://jobicy.com/jobs?search_keywords=Medical%20Device%20Software.md)[FDA Regulatory Compliance](https://jobicy.com/jobs?search_keywords=FDA%20Regulatory%20Compliance.md)[ISO 13485](https://jobicy.com/jobs?search_keywords=ISO%2013485.md)[IEC 62304](https://jobicy.com/jobs?search_keywords=IEC%2062304.md)[ISO 14971](https://jobicy.com/jobs?search_keywords=ISO%2014971.md)[CAPA](https://jobicy.com/jobs?search_keywords=CAPA.md)[Complaint Handling](https://jobicy.com/jobs?search_keywords=Complaint%20Handling.md)[Post-Market Surveillance](https://jobicy.com/jobs?search_keywords=Post-Market%20Surveillance.md)[AI/ML Medical Devices](https://jobicy.com/jobs?search_keywords=AIML%20Medical%20Devices.md) Sample interview questionsHow would you evaluate whether a reported late patient alert is a complaint and whether it may be MDR reportable?I would first collect the facts: intended use, patient impact, alert timing, clinical workflow, model and software version, logs, configuration, and any contributing data issues. I would assess the event against the complaint definition and document the investigation, then evaluate MDR criteria under 21 CFR 803, including whether the device may have caused or contributed to a death or serious injury or could do so if it recurred. I would escalate the reportability assessment for required review, preserve objective evidence, and initiate CAPA or trending if the event suggests a systemic issue. Describe your approach to maintaining traceability throughout a medical-device software release. I establish bidirectional traceability from user needs and system requirements through software requirements, architecture, risk controls, verification cases, validation evidence, anomalies, and release approval. For each release, I confirm that changed requirements and risks have appropriate testing, unresolved defects are dispositioned based on risk, and the design history file contains clear evidence of review and approval. I use practical tooling and dashboards so traceability remains current rather than becoming a manual end-of-release exercise. How would you assess an AI model update for regulatory impact? I would define the proposed change precisely, including model inputs, training data, algorithm behavior, performance metrics, intended-use implications, and deployment controls. I would evaluate the change against the risk management file, cleared indications, labeling, cybersecurity considerations, and any applicable FDA guidance or predetermined change control plan. The output would be a documented regulatory rationale identifying whether the change can proceed under internal change control, requires a letter-to-file, or warrants FDA engagement or a new submission. How do you work effectively with software engineers while preserving quality and compliance expectations? I engage early in planning and architecture discussions, translating regulatory requirements into concrete, right-sized engineering deliverables such as acceptance criteria, threat models, test evidence, and change-control checkpoints. When issues arise, I focus on objective evidence and patient risk rather than process for its own sake. This approach helps teams understand the purpose of controls and incorporates quality into the delivery workflow instead of treating it as a late-stage gate. What would you look for when improving a growing company's QMS for cloud-based clinical software? I would begin with a risk-based gap assessment of core processes: design controls, document control, training, supplier management, complaint handling, CAPA, cybersecurity vulnerability handling, computerized system validation, and management review. I would prioritize procedures that are usable by cross-functional teams, clearly define records and ownership, and align systems such as eQMS, Jira, and release tooling. I would then measure effectiveness through audit findings, cycle times, overdue actions, complaint trends, and the quality of evidence produced for releases and inspections. Opportunity details ## About this role. ### Senior Design Quality Engineer ### In Brief We’re a rapidly growing startup on a mission to make healthcare proactive by empowering physicians, nurses, and care team members with real-time data to save lives. You’ll safeguard product quality for an FDA-cleared, AI-driven clinical platform, from design controls while we build, to complaint investigation once it’s live in hospitals, to the quality system and regulatory record that hold it all together. ### Who We Are Bayesian Health’s mission is to improve patient outcomes by empowering clinicians with the insights they need to make the right decision for the right patient at the point of care. We’re a diverse team of clinicians, engineers, AI experts, product designers, and performance improvement leaders committed to enabling smarter, patient-specific care delivery through unlocking the power of data. We’re funded by top tier tech and biotech investors: Obvious Ventures, Andreessen Horowitz, American Medical Association’s venture arm, Catalio Partners, and LifeForce Capital. Recent recognitions include Forbes AI Top 50, World Economic Forum Tech Pioneer, Time Best Inventions, and BioTech AI Company of the Year. Read more about our peer-reviewed research in Nature Medicine associating our products with improved patient outcomes. ### About the Role Bayesian ships FDA-cleared, AI clinical decision support software directly into Epic and Oracle Health workflows at health systems across the country. Every release, every model update, and every clinician report that an alert didn’t behave as expected runs through a quality and regulatory system that has to be as rigorous as the software itself. You will help drive that system. This role intentionally wears multiple hats. We’re a small company, and we need one person who can do several things well: engineer quality into the software as it’s built, handle the post-market side once it’s in production, and keep the quality management system and our regulatory obligations current as we scale. You’ll work directly with engineering, data science, clinical, and implementation teams, with support from company leadership, while under the direction of the Head of Quality and Regulatory. You’re the engineer in the room on quality questions. When a hospital reports that the model flagged a patient late, you decide whether it’s a complaint, whether it’s reportable, and what changed in the software or the data. You can read the code, the logs, and the test evidence to find out. ### What You’ll Own ### Software Design Quality Partner with engineering and data science through the full software lifecycle: requirements, architecture review, software risk analysis, verification and validation, traceability, and release readiness in accordance with IEC 62304, ISO 14971, and 21 CFR 820 (QMSR) design controls. Keep the design history file and risk management file current, right-sized, and defensible. ### Change Control & Algorithm Lifecycle Assess software and model changes for regulatory impact, determining whether a letter-to-file or a new submission applies, and drive the change through the quality management system. Maintain the risk file and support post-market performance monitoring of the deployed algorithm. ### Complaint Handling & Post-Market Surveillance Support complaint intake, triage, investigation, and closure. Prepare MDR reportability assessments under 21 CFR 803 for review and approval, trend complaints and field data, and lead nonconformance reports and CAPAs when patterns emerge. Work closely with the implementation and clinical teams, who hear from clients first, to make sure feedback reaches the quality system. ### QMS Improvement & Maintenance Maintain and update quality procedures, document control, training records, and compliance evidence as the company grows. Support internal audits, prepare management review inputs, and manage supplier controls for EHR, cloud, and subcontractor relationships. ### Regulatory Interactions & Submissions Contribute to 510(k)s, Q-Submissions, and Predetermined Change Control Plans. Respond to FDA questions and support the team during FDA inspections. ### Regulatory Intelligence Monitor FDA guidance on AI/ML-enabled devices, cybersecurity under Section 524B, and quality system expectations. Translate emerging requirements into concrete changes to procedures and product requirements. ### Cross-Functional Collaboration Embed compliance into how product, engineering, and commercial teams already work, so that quality speeds delivery rather than slowing it down. Communicate quality metrics and risk clearly to technical and non-technical audiences, including executives. ### What You’ll Bring * A BS in Computer Science, Systems Engineering, Biomedical Engineering, or a related technical field, or equivalent practical experience * 5+ years in software quality, design quality engineering, or regulatory work for software medical devices under ISO 13485 and IEC 62304, including hands-on ownership of design controls and ISO 14971 risk management files * Experience with complaint handling and adverse event reportability decisions under 21 CFR 803 and 21 CFR 820 (QSR or QMSR), including complaint investigation, trending, and CAPA * A track record of writing, maintaining, and improving QMS procedures, document control, and change management in a regulated software environment * The ability to read code, logs, and automated test results well enough to investigate a software issue independently, and comfort working with engineers in a cloud-based SaaS environment * Working knowledge of FDA premarket cybersecurity expectations under Section 524B, including threat modeling, SBOM management, and vulnerability handling * Excellent written communication. You produce audit-ready records and can explain regulatory concepts to engineers, clinicians, and executives without losing precision * A high level of drive, a process-fixer mindset rather than a process-follower one, and the ability to learn fast and communicate clearly * Current, unrestricted authorization to work in the United States ### Nice to Haves * Experience with AI/ML-enabled medical devices, including algorithm change control, Predetermined Change Control Plans, model performance monitoring, and FDA AI/ML guidance * Direct experience preparing 510(k)s or Q-Submissions and corresponding with FDA reviewers * Familiarity with EHR-integrated software such as Epic or Oracle Health, SMART on FHIR, or CDS Hooks, and the security and quality due diligence enterprise health systems perform on vendors * Experience supporting a lead or primary contact in FDA inspections, ISO 13485 certification audits, or customer audits * Experience with eQMS platforms, Jira-based defect tracking, and computerized system validation * An ASQ CQE/CSQE, RAC, or equivalent quality or regulatory certification ### Life at Bayesian We’re a small, mission-driven team building AI tools that help clinicians catch life-threatening conditions earlier. We work remotely but stay closely connected in real time. We believe that closer collaboration helps us move faster for the hospitals and patients who depend on us. Our values guide how we work every day: * Patients at the center. We hold ourselves to a high bar for excellence and impact. * Hard problems, real breakthroughs. We pursue new ideas even when it’s uncomfortable. * No surprises, clear signals. We communicate clearly and honestly, so teams and customers can trust us. * Whole people, shared respect. We treat teammates with respect and make space to grow. * Truth seekers, stronger together. We debate openly and align around shared goals. ### What We Offer * Medical, Dental & Vision: Coverage through Anthem Blue Cross Blue Shield, including an HSA-eligible option, plus dental and vision through Guardian/VSP. Bayesian covers the majority of your premium and a meaningful share of your dependents’ coverage. Enrolled members also get access to One Medical for same-day and 24/7 virtual primary care. * Life & Disability: Life insurance, short-term disability, and long-term disability, fully company-paid. * 401(k): A company retirement plan with your choice of investment approach. * Wellbeing: Free mental health support through Spring Health, plus additional wellness resources including pet care benefits and more. * Time Off: Generous PTO that grows with tenure, paid sick time, paid holidays, and occasional company-wide self-care days. * Equity: You’ll also receive equity, so you share directly in what we build together. * Team Retreats: A fully paid annual company retreat to connect with the team in person. * Equipment: Your choice of Mac hardware, a one-time home office stipend, and ongoing reimbursement for internet and phone costs. Team: Quality & Regulatory Reports to: Head of Quality & Regulatory Level: Senior individual contributor Employment Classification: Full-Time with Benefits FLSA Status: Exempt Location: Remote – US Only Salary: $142,768 – $161,901 Candidates based in certain high-cost cities may be eligible for a geographic premium. Equity: Eligible Synchronous Hours: 11a-5p ET (8a-2p PT) Bayesian Health provides equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law. Bayesian Health is committed to providing reasonable accommodations to qualified individuals, including for disability, pregnancy-related conditions, and religious practice. If you need accommodation during the application or interview process, contact careers@bayesianhealth.com. Candidates must have current, unrestricted authorization to work in the United States. Bayesian Health does not provide visa sponsorship for this position. Bayesian Health participates in E-Verify. This job posting describes the general nature of the role. Employment with Bayesian Health, if offered, is at-will, and duties may evolve over time. 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