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