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.