Description

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.

Responsibilities

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.

Qualifications

Career Level - IC4

Senior Staff Clinical Consultant

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