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Senior Engineer, Product Development

Company: Integra LifeSciences
Location: Mansfield
Posted on: July 23, 2021

Job Description:


The Senior Product Development Engineer works as a member of sustaining engineering team supporting CSS platforms and will be responsible for design modifications of existing products including full product development cycle required by the latest Integra quality system.

 

  • Understanding of Medical Device-New product development and Sustaining Engineering Process,
  • Working knowledge of Technical files and Medical Device product development process,
    Knowledge of current European Medical Device directives (MDD/MDR) and CE Mark process,
  • Leading CAPAs (corrective action and preventive action) from initiation to closure
  • Understanding of Medical regulatory standards is preferred (EU Regulations – MDD & MDR)
  • Knowledge on Part 820, Part 11, ISO 13485, MDD/IVDD, IEC 60601x, IEC 62304, ISO 14971,
  • Create or update Risk Management (DFMEA, PFMEA, AFMEA), DHF, and Tech File documentation 
  • Write and review engineering test protocols for testing of component parts and integrated systems. 
  • Design and develop new products, processes and methods, and design experiments using appropriate software tools and statistical methodology
  • Instruct technical support staff and contractors and coordinate tasks as required. 
  • Execute or supervise key technical project activities such as design verification testing, sterilization validation testing, cleaning and disinfection validation testing, reprocessing testing, ISO 10993 related biocompatibility testing, shelf life testing, packaging validation testing, and ISTA shipping validation testing. 
  • Should have good communication skills to be able to communicate with steak holders, project managers, outside vendors,
  • Provide extensive engineering documentation with proper use of laboratory notebooks, spreadsheets and graphical summary of results in support of development, intellectual property applications, regulatory FDA filings, and verification and validation protocols.
  • Travel as needed to domestic and international vendor sites, company locations, and clinical settings. 
  • Experience with statistical analysis
  • Experience with MS Project, MS Office

  • B.S. or equivalent in a scientific discipline with 5 - 7 years of applied experience; A M.S. with 3 - 5 years of applied experience; A PhD with 0 – 2 years of applied experience or comparable applied experience in medical device, biotech or adjacent market segments.
  • Experience with CAD tools (Creo, Solidworks) is desirable
  • Experience with FEA tools is desirable
  • Experience in performing root cause investigations and resolving CAPAs
  • Experience working in a multifunctional team 
  • Strong time/project management skills (preferably experience using Microsoft Project or another project management software)
  • Experience working in a medical device environment would be desirable, but not mandatory

Keywords: Integra LifeSciences, Boston , Senior Engineer, Product Development, Other , Mansfield, Massachusetts

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