Product Risk Manager in Andover, MA at Johnson Service Group

Date Posted: 10/16/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Andover, MA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    10/16/2019

Job Description

JobID: 371183

A world leader in the manufacturing of medical devices and safety equipment is seeking a Product Risk Manager with expertise and experience in product development life cycle with internal and external standards for a 6 months to 1 year contract position to work in Andover, Massachusetts.

Pay Rate : $65.00/ hr.

Principal Accountability

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 EU MDR, industry Standards and FDA Regulations and Guidances to ensure risk management requirements and principles are implemented in the development of products.

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 company 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.

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 and 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.

JOB REQUIREMENTS 

B.S. degree in engineering or clinical discipline, Master`s degree a plus.

8+ years in electromechanical device design and 5 + years experience in risk management for medical devices or other regulated industry.

Experience in the field of patient monitoring and a broad technical knowledge in mechanics, electronics and experience managing risk.

Proficiency with risk management tools, including FMEA, FTA and FMECA.

Knowledge of usability or human factors engineering for medical deviices and GMP`s as defined by the FDA, 

Familiarity with UL, CSA, IEC/EN and other regulatory standards and experience in collaborating with multidisciplinary teams.

Johnson Service Group is a leading staffing agency specializing in a variety of industries. Having been named to three Staffing Industry Analysts (SIA) lists for the third year in a row, JSG continues to grow and offer hiring solutions to companies across the United States.  JSG serves both busy recruiters and qualified candidates within multiple industries from our major offices headquartered in Chicago and Atlanta with local offices throughout the United States and Canada.

Contact: Rich Hanson @ rhanson@jsginc.com