SENIOR SUPPORT ENGINEER

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Company: HCL Technologies

Location: Waukesha, WI 53188

Description:

Job Description (Posting).

Job: Biocompatibility and toxicology engineer
Location:Waukesha, WI
JD:
  • Support and consult on projects related to biocompatibility issues and challenges to resolve.
  • Author biocompatibility strategy and toxicological risk assessment per ISO 10993 - 1, ISO 10993 - 18, ISO 10993 - 17, ISO 18562 - 1, 2, 3, and 4.
  • Perform biocompatibility gap analysis and write summary report.
  • Review biocompatibility test reports, raw data, and protocols for accuracy, quality, and correctness.
  • Familiar with medical devices used in breathing gas pathways (e.g., Incubator, Warmer, Anesthesia systems, etc.)


    • Qualification:
  • Bachelor's in chemistry, Biology, Pharmacology, Material Science, or related field (or higher)
  • At least 3 - 5 years of experience in medical device or pharmaceutical industry or contract research laboratory
  • Knowledge of ISO 10993 series of requirements, ISO 18562 series requirements, and FDA guidance for biocompatibility
  • Strong time management skills to prioritize, organize, track details, and meet deadline for multiple projects.

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