Getinge Job - 34166995 | CareerArc
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Company: Getinge
Location: Merrimack, NH
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech


Job Function Summary

Manage Biocompatibility program by documenting and coordinating testing to support sustaining engineering and new product development activities.  Perform scientific risk assessments to support design control activities. 

Job Functions

Pre-clinical Science and Biocompatibility:

  • Manage Biocompatibility studies by writing protocols, coordinating testing between internal and external testing resources, and insuring that studies are completed on time and within budget.
  • Serve as department representative in cross-functional team meetings.
  • Provide technical input into 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. 
  • Develop internal procedures and standards for maintenance of Biocompatibility program as required.
  • Assists in special projects as needed. 
  • Contributes to team effort by accomplishing related duties as requested.


Required Knowledge, Skills and Abilities:

  • Experience in pre-clinical science/Biocompatibility testing in medical device, pharmaceutical, or biotechnology industries.
  • Demonstrated ability to manage project deliverables and manage timelines.
  • Strong statistical analysis skills. 
  • Excellent communication, interpersonal, writing and computer skills.
  • Experience with GLP (21 CFR 58) regulations 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) and serving as a study director.


Minimum Requirements:

  • BS/MS in Physical or Biological science/engineering.
  • Minimum of 5-10 years of related experience in the medical device industry is required. 


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