Senior Risk Management Engineer

Warwick Consulting; Boston (MA); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Hybrid work model

Travel opportunities

Job summary

Warwick Consulting Limited is seeking an experienced Senior Risk Management Engineer to lead risk management for medical device capital equipment across the product lifecycle, including design, development, manufacturing, commercialization, and post‑market activities. The role requires hands‑on experience with hazard analyses, risk controls, residual risk evaluation, and regulatory compliance.

You will collaborate with Engineering, Quality, Regulatory Affairs, R&D, and Manufacturing, with

Qualifications

• Bachelor's degree in Engineering, Biomedical Engineering, or a related technical discipline.
• Minimum 7+ years of relevant experience in medical device risk management, product safety, quality engineering, systems engineering, or a closely related discipline.
• Demonstrated experience with medical device capital equipment, preferably complex electromechanical systems or integrated hardware and software.
• Strong knowledge of ISO 14971 and FDA QMSR requirements and their application to medical device risk management.
• Hands-on experience with FMEA, FTA, and risk-based assessment methodologies.
• Experience developing and maintaining risk management plans, hazard analyses, risk management files, and reports.
• Ability to establish traceability between hazards, risk controls, verification evidence, and residual risk evaluations.
• Experience collaborating with Engineering, Quality, Regulatory Affairs, and cross-functional technical teams.
• Willingness and ability to travel internationally when required.

Responsibilities

• Lead risk management activities for medical device capital equipment across design, development, manufacturing, and post‑market phases.
• Develop, review, and maintain risk management plans, analyses, files, and reports in accordance with ISO 14971 and regulatory requirements.
• Apply FMEA, FTA, and RBA methodologies to identify hazards, analyze failure modes, evaluate risks, and establish mitigation strategies.
• Evaluate the effectiveness of risk controls, including residual risk and acceptability.
• Facilitate risk assessments involving mechanical, electrical, software, and integrated systems.
• Assess complaints, nonconformances, CAPAs, design changes, and post‑market information for impact on safety.
• Integrate risk management into design controls, verification/validation, change management, and lifecycle processes.
• Prepare and maintain risk management documentation and traceability.

Skills

ISO 14971

FDA QMSR

FMEA

FTA

RBA

Design controls

Hazard analysis

Risk communication

Education

Bachelor's degree in Engineering or Biomedical Engineering

Job description

Warwick Consulting is a medical device and life sciences consulting firm providing comprehensive solutions across the product lifecycle, from concept and design to regulatory approval, commercialization, and post-market support.

We partner with emerging innovators and global industry leaders, offering expertise in engineering, quality systems, regulatory affairs, cybersecurity, risk management, human factors engineering, product quality, and FDA remediation.

Through experienced consultants and innovative, AI-enabled solutions, including our VERA QMS Assurance platform, we help clients strengthen compliance, improve operational efficiency, manage complex challenges, and accelerate innovation. Our flexible consulting model supports on-site, hybrid, and remote engagements.

Position Overview

We are seeking an experienced Senior Risk Management Engineer to lead and support risk management activities for medical device capital equipment throughout the product lifecycle, including design, development, manufacturing, commercialization, and post-market activities.

The ideal candidate will possess strong expertise in ISO 14971, FDA Quality Management System Regulation (QMSR), Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA), and Risk-Based Assessments (RBA).

This role requires hands‑on experience identifying product hazards, evaluating device‑level risks, implementing risk controls, maintaining risk management documentation, and ensuring regulatory compliance.

The successful candidate will collaborate with Engineering, Quality, Regulatory Affairs, R&D, Manufacturing, and global stakeholders to support product safety and effective risk‑based decision‑making. Periodic international travel will be required.

Key Responsibilities

1. Risk Management and Product Safety

Lead risk management activities for medical device capital equipment across design, development, manufacturing, and post‑market phases.

Develop, review, and maintain risk management plans, analyses, files, and reports in accordance with ISO 14971 and applicable regulatory requirements.

Apply FMEA, FTA, and RBA methodologies to identify hazards, analyze failure modes, evaluate risks, and establish appropriate mitigation strategies.

Evaluate the implementation and effectiveness of risk controls, including residual risk and overall residual risk acceptability.

Facilitate risk assessments involving complex mechanical, electrical, software, and integrated medical device systems.

Assess complaints, nonconformances, CAPAs, design modifications, and post‑market information for potential impact on product safety.

Integrate risk management into design controls, verification and validation, change management, and product lifecycle processes.

2. Risk Analysis and Documentation

Conduct structured hazard analyses covering foreseeable sequences of events, hazardous situations, potential harms, and associated risks.

Perform design, process, and system‑level FMEAs to evaluate failure modes, effects, causes, and risk reduction opportunities.

Apply Fault Tree Analysis to identify individual failures and combinations of events that could contribute to hazardous outcomes.

Conduct risk‑based assessments to support prioritization, technical decisions, and appropriate risk controls.

Maintain traceability between identified hazards, risk estimates, risk controls, verification evidence, residual risk evaluations, and conclusions.

Review risk analyses for technical accuracy, completeness, consistency, and compliance with established acceptance criteria.

Prepare and maintain clear, controlled, and inspection‑ready risk management documentation.

3. Capital Equipment and Systems Risk

Evaluate risks associated with complex medical device capital equipment, considering intended use, operating conditions, system architecture, interfaces, and foreseeable misuse.

Collaborate with engineering subject matter experts to understand device functionality, failure mechanisms, and potential impacts on patients and users.

Assess risk implications of design changes, component modifications, supplier changes, manufacturing updates, and software revisions.

Integrate risk management with systems engineering, design assurance, usability engineering, verification and validation, and manufacturing activities.

Identify opportunities to improve the quality, consistency, and effectiveness of risk analysis across product teams.

Ensure risk management decisions are technically justified, proportionate, and aligned with product safety objectives.

4. Regulatory and Quality System Compliance

Apply ISO 14971 and FDA QMSR requirements to medical device risk management processes and documentation.

Align risk management activities with ISO 13485, applicable FDA requirements, design and development controls, and relevant product‑specific standards.

Support regulatory submissions, quality audits, inspections, and compliance assessments through accurate risk documentation.

Work with Quality and Regulatory Affairs teams to interpret regulatory requirements and translate them into practical risk management activities.

Support improvements to risk management procedures, templates, analytical methods, and quality system processes.

Ensure risk management records demonstrate a systematic, evidence‑based approach to product safety and regulatory compliance.

5. Cross‑Functional and Global Collaboration

Partner with R&D, Engineering, Quality, Regulatory Affairs, Manufacturing, Service, and other functions to identify and manage product risks.

Lead risk management workshops, technical reviews, and cross‑functional discussions concerning hazards, failure modes, risk acceptability, and mitigation strategies.

Communicate complex risk concepts, technical findings, and recommendations to engineering teams, management, and other stakeholders.

Influence risk‑based decisions through clear technical analysis and well‑supported recommendations.

Coordinate risk management activities across geographically distributed teams.

Track project actions, dependencies, milestones, and potential issues, escalating concerns when necessary.

Participate in international workshops, technical reviews, and project activities as required.

6. Technical Subject Matter Expertise

ISO 14971 Risk Management: Risk management planning, hazard identification, risk estimation, evaluation, control, and reporting.

Failure Modes and Effects Analysis: Design FMEA, Process FMEA, and other relevant methodologies.

Fault Tree Analysis: Deductive analysis of failures and combinations of events leading to hazardous outcomes.

Risk‑Based Assessments: Structured analytical approaches for evaluating risks and supporting technical decisions.

Risk Control Verification: Verification of implementation, effectiveness, traceability, and residual risk.

Design and Lifecycle Integration: Alignment with design controls, verification and validation, product changes, and post‑market activities.

Documentation and Change Control: Maintaining accurate, controlled, traceable, and audit‑ready risk management records.

Required Qualifications

Bachelor's degree in Engineering, Biomedical Engineering, or a related technical discipline; equivalent relevant experience may be considered.

Minimum 7+ years of relevant experience in medical device risk management, product safety, quality engineering, systems engineering, or a closely related discipline.

Demonstrated experience with medical device capital equipment, preferably complex electromechanical systems or integrated hardware and software.

Strong knowledge of ISO 14971 and FDA QMSR requirements and their application to medical device risk management.

Hands‑on experience with FMEA, FTA, and risk‑based assessment methodologies.

Experience developing and maintaining risk management plans, hazard analyses, risk management files, and reports.

Ability to establish traceability between hazards, risk controls, verification evidence, and residual risk evaluations.

Experience collaborating with Engineering, Quality, Regulatory Affairs, and cross‑functional technical teams.

Strong analytical, problem‑solving, technical writing, communication, and facilitation skills.

Ability to work independently, manage competing priorities, and make technically sound decisions.

Willingness and ability to travel internationally when required.

Preferred Qualifications

Experience supporting complex medical device capital equipment through design, development, manufacturing, commercialization, and post‑market activities.

Familiarity with IEC 60601 series, IEC 62304, IEC 62366, and other applicable medical device standards.

Experience integrating risk management with design controls, verification and validation, CAPA, complaint handling, and change control.

Experience collaborating with geographically distributed teams within global medical device organizations.

Familiarity with risk management software, electronic Quality Management Systems (eQMS), and Product Lifecycle Management (PLM) tools.

Work Arrangement

This is a hybrid consulting engagement involving on‑site collaboration and remote work based on project requirements and client expectations.

The successful candidate must be comfortable working independently, collaborating directly with client engineering and quality leadership, and taking ownership of assigned risk management and remediation activities with minimal supervision.

Periodic international travel may be required to support technical workshops, risk management reviews, and project milestones.

Equal Opportunity Employer

Warwick Consulting is committed to providing equal employment opportunities and maintaining a diverse and inclusive workplace.