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Sr. Staff Product Risk Mgr

Company: Draeger Medical Systems, Inc.
Location: Andover
Posted on: September 25, 2022

Job Description:

The Job ResponsibilitiesProvides 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 Draeger process. Serves as corporate resource serving as spokesperson in the industry internally & externally 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 Draeger and competitive products, including Draeger 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. Your QualificationsEducation: Bachelor's degree in engineering or clinical discipline, Master's degree a plus. Related Experience: 5+ years relevant experience in risk management for medical devices or other regulated industry * Experience in the field of patient monitoring a plus 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 * 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 Familiarity with UL, CSA, IEC/EN and other regulatory standards Skilled in collaborating with multi-disciplinary teams Master problem solver / decision maker Innovative/creative Leadership & coaching qualities Strategic thinker Results driven

Keywords: Draeger Medical Systems, Inc., Boston , Sr. Staff Product Risk Mgr, Other , Andover, Massachusetts

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