- $96,900.00 -143,000.00/year*
26 Bristol St
Job Description Summary
The Senior Post Market Surveillance (PMS) Engineer will collect, analyze, trend and report on safety data to proactively identify potential adverse safety risks or performance trends. Provides clinical and safety data assessment of post-marketing events. The incumbent will collaborate with cross-functional team members to ensure compliance to the applicable regulations, standards and company policies/procedures to help improve the lives of the people we serve by ensuring high standards of quality and safety of the medical devices being produced. Key Performance Indicator metrics are measured and analyzed for continuous improvement opportunities with subsequent action taken as appropriate. This position plays an integral role in maintaining compliance with global regulations.
Job Description Work with PMS team to meet the requirements in generating PMS, Post Market Clinical Follow-up (PMCF), Clinical Evaluation Report (CER), Periodic Safety Update Report (PSUR), Summary of Safety and Clinical Performance (SSCP) and related reports along with supporting the maintenance of appropriate Design History File (DHF) documents such as Risk Management Files (RMF). Assist complaint investigators as necessary. Extract and generate PMS and operational performance data necessary for generating applicable reports. Analyze and interpret clinical and PMS data. Identify and escalate instances when products are not achieving the intended performance based upon anticipated levels of frequency and/or severity. Maintain procedures as necessary. Support responding to requests for additional information from competent authorities, registries and notified body. Support internal and external audits. Develop and maintain knowledge of support systems including MasterControl, JDE and TrackWise. Complete training by established due dates. Identify and escalate quality and personnel issues as necessary. Performs other related duties and responsibilities as assigned.
Skills and Experience Sound working knowledge of regulations and industry standards consistent with requirements for a manufacturer of globally distributed medical devices and pharmaceutical products. Strong computer skills and previous application of Microsoft Excel, Word, PowerPoint, Project, Visio, database management, statistical analysis and reporting packages. Ability to acquire, query and analyze data with focus on detail. Analytical skill and focus on detail. Good written and verbal communication, problem solving and applied thinking skills. Team player with ability to successfully interact with representatives from a variety of disciplines within and external to BDI Surgery and Becton Dickinson.
Minimum Requirements Bachelor of Science Degree in Engineering or Technical discipline required. 5-8 years of relevant experience in the Medical Device and/or other regulated industry (Pharma, IVD).
Primary Work Location
USA RI - Warwick
Associated topics: biochemistry, biomedical, biomedical engineer, bioprocess, enzyme, molecular, msat, neuro, neuroscience, parenteral
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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