Principal Clinical Consultant

Required Qualifications:

• Licensed clinician (RN, PharmD, MD, NP, PA, or equivalent) with 10+ years of clinical experience.
• Minimum 10+ years experience in product management, clinical informatics, or usability/human factors engineering within healthcare technology or medical devices.
• Knowledge of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance related to medical device software (SaMD).
• Strong understanding of clinical risk, safety analysis, and usability validation methodologies.
• Proven ability to translate complex clinical workflows into clear design and engineering requirements.
• Excellent cross-functional communication and documentation skills.

Preferred:

• Experience supporting regulatory submissions or audits (EU MDR, FDA 510(k), etc.).
• Experience working with AI-driven medical device applications or software as a medical device (SaMD).
• Familiarity with Oracle Health/Cerner Millennium or similar EHR platforms.
• Advanced degree in healthcare informatics, biomedical engineering, or related field.

Key Responsibilities:

• Conduct and contribute to clinical risk analyses (per ISO 14971).
• Collaborate on Failure Mode and Effects Analyses (FMEAs), hazard analyses, and usability studies for clinical safety.
• Partner with engineering teams to identify and mitigate clinical risks across design and implementation.
• Serve as a Clinical and Product-Focused Specialist, providing deep domain expertise in clinical workflows, usability, and patient safety.
• Provide clinical context for Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements.
• Oversee usability engineering (IEC 62366), ensuring requirements map to user needs and validation meets usability and human factors standards.
• Lead change management oversight across device-relevant business areas (internal and external), ensuring documentation, communication, and validation of changes.
• Act as a bridge between Product Management, Clinical Safety, and Health Compliance Organizations (HCOs).
• Facilitate regulatory awareness and readiness across the broader product organization.
• Partner closely with Medical Device Tiger Teams and transition into broader next-generation device initiatives.