Sr Medical Device Risk Manager

Greater Boston area, Massachusetts

Posted: 08/18/19 Category: Software/Application Development and Architecture Job Number: 8132

Position Title: Sr Medical Device Risk Manager

Job Location: Greater Boston area

Interview Expectations: onsite

Local Candidate: yes

Required Skill Sets: med device, risk management

Description:

 
  • This individual contributor 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 organizational process. Serves as corporate resource serving as spokesperson in the industry internally & externally
  • Provides leadership and expertise to the teams for the latest in the EU MDR, industry Standards and FDA Regulations and Guidances to ensure risk management requirements and prinicples are implemented in the development of products, and ongoing product monitoring.
  • 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.
  • Reviews post-market surveillance data for the organization and competitive products, including 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. Highly skilled at smart risk taking & removing impediments & inefficiencies.
  • 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 influence product or system architecture and design resulting in improved product safety. Highly productive working multiple & significant assignments simultaneously.
  • Assesses product non-conformities and provides sound risk/benefit rationale for deferred defects. Skilled at managing & meeting commitments across projects internally & externally.
  • 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.

 

Qualifications

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

Related Experience:
  • 15+ years experience in a development of electro-mechanical devices with embedded software.
  • 10+ 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
  • Master problem solver / decision maker
  • Leadership & coaching qualities
  • Strategic thinker
  • Results driven

 

Description:

 
  • This individual contributor 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 organizational process. Serves as corporate resource serving as spokesperson in the industry internally & externally
  • Provides leadership and expertise to the teams for the latest in the EU MDR, industry Standards and FDA Regulations and Guidances to ensure risk management requirements and prinicples are implemented in the development of products, and ongoing product monitoring.
  • 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.
  • Reviews post-market surveillance data for the organization and competitive products, including 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. Highly skilled at smart risk taking & removing impediments & inefficiencies.
  • 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 influence product or system architecture and design resulting in improved product safety. Highly productive working multiple & significant assignments simultaneously.
  • Assesses product non-conformities and provides sound risk/benefit rationale for deferred defects. Skilled at managing & meeting commitments across projects internally & externally.
  • 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.

 

Qualifications

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

Related Experience:
  • 15+ years experience in a development of electro-mechanical devices with embedded software.
  • 10+ 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
  • Master problem solver / decision maker
  • Leadership & coaching qualities
  • Strategic thinker
  • Results driven

 

Kathryn Egizi
Technical Recruiter

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