Senior Design Quality Engineer

Jobicy; Northern (KY); On-site; USD 143,000 - 162,000; Full time

Job summary

Bayesian Health, a fast-growing startup, is seeking a Senior Design Quality Engineer to ensure design controls, regulatory compliance, and post-market surveillance for an FDA-cleared AI clinical decision support platform.

You will own software design quality, evaluate changes for regulatory impact, manage complaint handling, MDR assessments, and maintain the quality management system as the team scales, working with engineering, data science, clinical and implementation teams.

Qualifications

• Must understand design controls and regulatory obligations for medical device software.
• Experience implementing traceability from requirements to release evidence.
• Familiarity with post-market surveillance and CAPA processes.

Responsibilities

• Engineer quality into software as it’s built and through release readiness.
• Handle post-market activities including complaint handling and MDR assessments.
• Maintain the quality management system and regulatory records as the company scales.

Skills

Traceability

Regulatory compliance

Software design quality

FDA/IEC 62304

Job description

# Senior Design Quality EngineerReview the role, location requirements, compensation details, and application process before deciding whether this opportunity fits your next career move.Experience: SeniorSee how your resume can be rewritten and optimized for this specific job. PRO identifies relevant strengths, missing keywords, and opportunities to present your experience more clearly.**Illustrative PRO preview** Example output format. Your recommendations will be generated from your resume and this job. **Original:** Responsible for leading projects and working with different teams.**Suggested rewrite:** Led a cross-functional initiative that improved **[business outcome]** by **[measurable result]**, demonstrating experience relevant to this role...Compare your resume with this job's requirements. PRO highlights your strongest matches, identifies potential gaps, and recommends practical next steps for your application.**Illustrative PRO preview** Example output format. Your actual assessment will be generated from your resume. 1. **Overall Match:** A personalized match level with an explanation of how your experience aligns with the role.2. **Key Strengths:** Skills, achievements, and experience that support your application.3. **Potential Gaps:** Requirements that are missing or not clearly demonstrated in your resume.4. **Recommendation:** Specific improvements to strengthen your application...Create a personalized cover letter using this job's requirements and the verified experience in your resume. PRO helps connect your strengths with what the employer is seeking.**Illustrative PRO preview** Example output format. Your letter will be personalized using your resume and this job. Dear Hiring Manager, I am excited to apply for this position. My experience in **[relevant area]** and track record of **[measurable achievement]** align with the role's key requirements. I would welcome the opportunity to bring these strengths to your team and contribute to **[business objective]**...## Role DNAA quick view of the complexity, pace, ownership and collaboration implied by the job description.**AI insight**This 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 analysisEstimated compensation compared with the broader US market for similar roles.**AI insight**The 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 skillsSkills and capabilities most closely associated with this opportunity.**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.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.Opportunity details## About this role.### Senior Design Quality Engineer### In BriefWe'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 AreBayesian 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 RoleBayesian 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