Job Description

POSITION: Sr. Staff Product Risk Manager LOCATION:  Greater Boston Area JOB TYPE: Temp or perm DURATION: 6-12 months

THE JOB RESPONSIBILITIES

• We are looking for a talented individual to join our patient monitoring team to help deliver new features and product enhancements that will improve patient outcomes and reduce the cost of medical care around the world.
• This individual provides risk management expertise and leadership throughout the product development life cycle in accordance with internal processes and external standards.
• Leads the risk management process throughout the development cycle, ensuring that risks are identified, control measures are defined, verified and effective, in accordance with ISO 14971 and company process.
• Provides leadership and expertise to the teams for the latest in EU MDR, industry Standards and FDA Regulations and Guidances to ensure risk management requirements and principles are implemented in the development of products and ongoing product support.
• Creates and maintains product-related files and reports (e.g. Product Risk Management File, Product Risk Management Report, Clinical Risk Management Report, Review of Post Production Information, Essential Requirements Checklist, List of Critical Components) that support compliance efforts and enhance product safety and performance.
• Provides risk management support for cybersecurity risk assessments of Common Vulnerability Scoring System (CVSS) working closely with product security experts (PSE’ s) and/or software subject matter experts (SME’ s)
• Reviews post-market surveillance data for company and competitive products, including company complaint data and publicly available adverse event databases (e.g. MAUDE) to anticipate potential issues and bring awareness to all appropriate stakeholders.
• Provides leadership and expertise to product development teams at a system level and within engineering disciplines to ensure risk management principles are applied throughout the design process.
• Collaborates with contributing disciplines such as electronics, mechanics, software, systems engineering, algorithms, product security, clinical, usability, production, service, regulatory, and user documentation to ensure risk activities are effectively and efficiently coordinated.
• Applies advanced technical knowledge and skill to influences product or system architecture and design resulting in improved product safety.
• Assesses product non-conformities and provides sound risk/benefit rationale for deferred defects.
• Provides product risk expertise input to Health Hazard Evaluations (HHEs) to improve responses to issues in the field; performs risk-benefit analysis and assesses and improves the risk management process resulting in improved overall product safety.
• Performs other duties as needed and assigned.

EDUCATION:

• Bachelors degree in engineering or clinical discipline, Master’ s degree a plus.

RELATED EXPERIENCE:

• 8+ years experience in the development of electro-mechanical devices with embedded software
• 5+ years relevant experience in risk management for medical devices or other regulated industry
• Experience in the field of patient monitoring and/or hospital networking

SPECIAL COMPETENCIES OR CERTIFICATIONS:

• A solid understanding of the potential sources of risk and how to manage risk
• Broad technical knowledge in mechanics, electronics, software and/or systems engineering
• Proficiency with risk management tools, including FMEA, FTA and FMECA
• Knowledge of usability or human factors engineering for medical devices
• Knowledge of GMPs as defined by the FDA
• Knowledge in requirements management with demonstrated proficiency using tools such as DOORS
• Familiarity with UL, CSA, IEC/EN and other regulatory standards
• Skilled in collaborating with multi-disciplinary teams

WORKING KNOWLEDGE OF THE FOLLOWING:

• Integrated Software
• Embedded Software
• Network systems
• Software Security
• Software coding or testing
• Systems Engineering
• Software modules
• Highly regulated environments