Getinge Job - 33839791 | CareerArc
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Company: Getinge
Location: Merrimack, NH
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech

Description

Job Function Summary:

Lead pre-clinical science and Biocompatibility programs using internal and external resources.  Perform scientific risk assessments to support design control activities.  Aid in the evaluation of new research and technology initiatives.  

Job Functions:

 

Pre-clinical Science and Biocompatibility:

  • Lead pre-clinical science and Biocompatibility programs.
  • Serve as a subject matter expert in cross-functional team meetings.
  • Prepare and defend regulatory documents.
  • Provide guidance and risk assessments on new product mat.
  • Provide technical leadership for project team activities, team members, peers, and cross functional counterparts.
  • Provide oversight for Non-Clinical studies by designing, reviewing, approving and managing studies with Contract Research Organizations (CRO).
  • Create Biological Evaluation of Risk (BER) files and maintain compliance of the Design History File.
  • Perform scientific risk assessments to support design control activities. 

 

Research and New Technology Evaluations:

  • Identify, adapt, and advance new technology initiatives.
  • Analyses of test data of new scientific theories and hypotheses.
  • Planning, executing, documenting and reporting lab activity to provide scientific date supporting marketing proof points of features on existing and new devices.
  • Develop internal procedures and standards for maintenance of laboratory investigation records, quality of invention releases, and feasibility experiment design.

 

Other Job Functions:

  • Assists in special projects as needed. 
  • Contributes to team effort by accomplishing related duties as requested.
  • May include management of technical staff.

 

Required Knowledge, Skills and Abilities:

  • Experience in pre-clinical science/Biocompatibility testing in medical device, pharmaceutical, or biotechnology industries.
  • Demonstrated research effectiveness; patents and/or publication in peer review journals, presentations forums, etc. 
  • Strong statistical analysis skills. 
  • Excellent communication, interpersonal, writing and computer skills.
  • Chemical, medical device, hygiene and/or Packaging industry experience strongly desired.  
  • Good laboratory and sciences skills expected, including documentation of activity. 
  • A detailed understanding of the product development process is preferred.

 

Additional Preferred Knowledge, Skills and Abilities:

  • Background in toxicology and experience with toxicological risk analysis.
  • Work in a medical device, pharmaceutical, or biotechnology contract research organization (CRO).

 

Minimum Requirements:  

  • MS/PhD in Physical or Biological science/engineering.
  • Minimum of ten-fifteen years of related experience in the medical device industry is required. 


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