Sr. R&D Verification Engineer: Therapeutics – MA (BH1336)

Our client, a global provider of industry-leading technologies, equipment and services to the pharmaceutical and biotech industry, is seeking a Sr. R&D Verification Engineer in the greater-Boston area.

Requirements:

  • BS in Mechanical, Plastics or closely related course of study, MS is a plus.
  • Minimum of 5 years medical device or life sciences engineering experience with a focus on V&V
  • Experience in equipment/disposables for cell/gene therapy or blood processing is preferred; however solid V&V experience in other medical device areas will be considered
  • While engineering strength is critical, some quality experience would be a plus
  • Experience performing IQ/OQ, designing and overseeing tests and then summarizing the data.
  • Experience evaluating manufacturing processing (process qualification) as well as suppliers for their level of fit with the project.

Responsibilities:

  • Set-up design of experiments (DOE) and perform verification and validation activities, and/or review plan and results within the R&D team, with focus on quality, compliance and execution rigor.
  • Assess product specifications or change controls for improving the robustness, usability or the manufacturing of new and existing devices.
  • Utilize Minitab for data analysis and statistical process improvement. Will analyze and interpret statistical data.
  • Support and evaluate R&D suppliers, such as a new injection molders, to determine the best fit for each project.

Location: Massachusetts

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