Principal Risk Quality Engineer

As the Principal Risk Quality Engineer, you will own the product Risk Management process and will serve as the global subject expert (SME) for Product Safety and Risk Management. You will be the architect of the risk lifecycle, ensuring that our digital health solutions—including SaMD and AI/ML-enabled technologies—are designed with a "Safety-First" mindset.

Your core responsibility will be leading the end-to-end Risk Management process (ISO 14971), from initial Hazard Analysis through Post-Market Risk surveillance, ensuring that clinical risks are identified, mitigated, and verified before reaching a patient.  As a global SME of Risk Management, you will train and coach teams on Risk Management and work collaboratively with cross functional engineers and Quality team members.  

Key Responsibilities

Strategic Leadership

• Risk Governance: Act as the primary authority on global risk standards, including ISO 14971, IEC 62304 (Risk focus), and ISO/TR 24971.
• Safety Architecture: Define the framework for evaluating risk in AI/ML (algorithmic bias/drift), Cloud Infrastructure, and Cybersecurity (AAMI SW96/TIR57).
• Cybersecurity:  Partner with Cybersecurity team to evaluate and address cybersecurity related risks and ensure processes adhere to U.S. and international standards and guidance documents.  
• Risk Culture: Lead cross-functional "Safety-by-Design" workshops, ensuring engineering and product teams understand the clinical impact of technical failures.

Design Quality & Risk Management

• Advanced Risk Modeling: Lead and facilitate comprehensive risk activities, including Hazard Analysis, Fault Tree Analysis (FTA), and FMEAs (System, Design, and Software).
• Benefit-Risk Analysis: Partner with Clinical Affairs to author Benefit-Risk Assessments (BRA) for global regulatory submissions.
• V&V Alignment: Ensure that the Software Verification & Validation (V&V) strategy is directly driven by the Risk Management File (RMF), ensuring all mitigations are rigorously tested.

Execution & Compliance

• Risk Management File (RMF) Ownership: Drive the creation and maintenance of the RMF from concept through commercialization, ensuring a "living document" approach.
• Post-Market Risk Surveillance: Lead the review of field performance data and complaints to update risk assessments and trigger Corrective and Preventive Actions (CAPA) when necessary.
• Health Hazard Evaluations (HHEs): Lead necessary HHE activities related to quality and safety issues.    
• Audit Representation: Serve as the global SME, defending the technical integrity of the Risk Management process and files and technical safety justifications during FDA, Notified Body, and MDSAP inspections.

Cross-Functional Collaboration

• Clinical Collaboration: Bridge the gap between technical software failures and clinical harms by working closely with Medical Affairs.
• Regulatory Submissions: Provide critical risk-based evidence for FDA 510(k)/PMA and EU-MDR technical files.

Skills Needed

• Mastery of Risk Estimation, Evaluation, and Control methodologies.
• Strong critical thinking skills with the ability to visualize complex system-level failure modes.
• Ability to translate technical software bugs into potential clinical patient harms.

Educational Requirements & Work Experience 

• Bachelor’s degree in Biomedical Engineering, Systems Engineering, or a related technical field; Master’s degree strongly preferred.
• 10+ years of experience in Risk Management or Quality Engineering within the medical device industry.
• Certifications (Preferred): ASQ Certified Risk Management Professional, Six Sigma Black Belt, or ISO 14971 Lead Auditor.

This position has an estimated base salary of $185,000 - $240,000, bonus, and equity. #LI-IB1; LI-Hybrid