Product Risk Manager

Company: Johnson Service Group
Location: Lawrence
Posted on: May 9, 2022

Job Description:

JSG Contact: Allen MudalelAMudalel@JSGInc.comOffice: (610) 828-7356Our client a world leader in the manufacturing of medical devices and safety diagnostics equipment is seeking Staff Product Risk Manager for their Andover, MA site. They offer competitive salary and benefitsJob PurposeProvides risk management expertise and leadership throughout the product development life cycle in accordance with internal processes and external standards. ResponsibilitiesLeads 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 Client's process. Serves as corporate resource serving as spokesperson in the industry internally & externallyCreates 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 Client and competitive products, including Client's 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.Education/ExperienceBachelor's degree in engineering or clinical discipline, Master's degree a plus.15+ years' experience in electromechanical device design5+ years relevant experience in risk management for medical devices or other regulated industryCompetencies Experience in the field of patient monitoring a plusA solid understanding of the potential sources of risk and how to manage riskBroad technical knowledge in mechanics, electronics, softwareProficiency with risk management tools, including FMEA, FTA and FMECAKnowledge of usability or human factors engineering for medical devicesKnowledge of GMPs as defined by the FDAKnowledge in requirements managementFamiliarity with UL, CSA, IEC/EN and other regulatory standardsSkilled in collaborating with multi-disciplinary teams Johnson Service Group has been named to the list of Largest Staffing Suppliers in the United States by the Staffing Industry Analysts SIA. Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.Please contact Allen Mudalel at 610 828-7356 and email resume to amudalel@jsginc.com www.JSGInc.com

Keywords: Johnson Service Group, Lawrence , Product Risk Manager, Executive , Lawrence, Massachusetts