Risk Management / HHE Specialist (Medical Devices)

PROLIM Global Corporation () is hiring a Risk Management / HHE Specialist (Medical Devices) for a leading global technology client.

Title : Risk & Health Hazard Evaluation (HHE) Specialist

Location :  Boston MA, Bothell WA preferred (Can be remote but need to visit client location if needed) 

Role Summary

We are seeking a skilled Risk & Health Hazard Evaluation (HHE) Specialist to support CAPA and post-market activities for ultrasound systems. This role is critical in ensuring patient safety, regulatory compliance, and effective risk management by evaluating field issues, complaints, and product non-conformances.

Key Responsibilities

Health Hazard Evaluation (HHE)

·         Perform HHE assessments for complaints, field issues, and non-conformances

·         Evaluate patient/user risk and determine severity and likelihood

·         Recommend actions such as Field Safety Corrective Actions (FSCA), recalls, or advisories

·         Support regulatory reporting decisions (FDA, EU MDR)

Risk Management

·         Conduct and update risk assessments per ISO 14971

·         Maintain and update:

o    Risk Management Files (RMF)

o    Hazard Analysis, FMEA, Fault Tree Analysis

·         Ensure risk controls are implemented and residual risks are acceptable

CAPA Support

·         Partner with CAPA teams on root cause investigations and corrective actions

·         Integrate risk evaluation into CAPA lifecycle

·         Perform effectiveness checks and risk reassessment post-implementation

Regulatory & Compliance

·         Ensure alignment with:

o    FDA 21 CFR Part 820

o    EU MDR

o    ISO 13485

·         Support audits, inspections, and regulatory submissions

Cross-Functional Collaboration

·         Work closely with:

o    R&D / Engineering

o    Quality & Regulatory Affairs

o    Clinical and Field teams

·         Provide risk-based input for product changes and issue resolution

Documentation

·         Prepare HHE reports, risk assessments, and CAPA documentation

·         Ensure traceability across complaints, CAPA, and risk files

·         Maintain audit-ready records

Required Qualifications

·         Bachelor’s or Master’s degree in Biomedical Engineering, Electronics, or related field

·         5–15 years of experience in:

o    Medical device risk management & CAPA

o    HHE / product safety evaluation

·         Strong knowledge of:

o    ISO 14971, ISO 13485

o    FDA and EU MDR regulations

·         Experience with diagnostic imaging systems (Ultrasound preferred)

Key Skills

·         Strong analytical and problem-solving skills

·         Ability to assess clinical and technical risks

·         Excellent documentation and communication skills

·         Stakeholder management across global teams

Preferred / Good to Have

·         Experience with Philips or similar medical device organizations

·         Familiarity with post-market surveillance systems

·         Six Sigma / Quality certifications

·         Understanding of ultrasound imaging technology

Apply now for immediate consideration.
Send your updated resume and contact details to:

About PROLIM Corporation

PROLIM is a leading provider of end-to-end IT, PLM and Engineering Services and Solutions for Global 1000 companies. They understand business as much as technology, and help their customers improve their profitability and efficiency by providing high value technology consulting, staffing, and project management outsourcing services.

Their IT and PLM consulting offerings include; Advisory, PLM Software/Services, Program Management, Solution Architecture Training/Staffing, Cloud Solutions, Servers/Networking, Infrastructure, ERP Practices and QA Services. Engineering services include Data Translation, CAD/CAM/CAE, Process & Product Engineering, Prototyping, and Testing/Validation within a wide range of markets and industries.