American Cybersystems, Inc.
Freelance / Contract
USA

Title: Biocompatibility Specialist IV (Fully Remote)

Duration: 6 Months

Hours: 8:00am to 5:00pm

Location: Neenah WI 54956 (this position can be fully remote)

Description/Comment:

Biocompatibility Specialist

Candidates with a degree in toxicology would be best

Seeking an experienced Biocompatibility Specialist to support product development and lifecycle management in terms of pre-clinical safety and biocompatibility of medical devices, materials and processes.

This role will work closely with project cross-functional teams to provide biocompatibility and other pre-clinical safety deliverables in compliance with ISO 10993 and other regulatory guidelines.

The role requires knowledge of the medical device biocompatibility discipline throughout the product lifecycle and knowledge of biocompatibility regulations as they pertain to Class I and Class II devices.

Candidate will work under the guidance of senior subject matter experts in biocompatibility and safety assessment, and must have strong ability to critically review scientific information and toxicology data.

Principal Responsibilities:

1. Conduct biological safety assessment of medical devices and components, taking into consideration identified hazard, user or patient exposure according to intended product use or foreseeable misuse; develop technically sound biocompatibility safety assessment reports.

2. Lead the design, monitoring and interpretation of chemical characterization analyses, pre-clinical toxicology, biocompatibility and microbiological safety studies conducted under Good Laboratory Practices (GLP), and when applicable, clinical studies conducted under Good Clinical Practices (GCP).

3. Evaluate new product and changes in products per organizational risk management practices to ensure effective, safe and complaint devices are released to the market.

Experience, education and knowledge requirements:

1. Bachelor of Science degree in toxicology, biomedical engineering, biological sciences or related field; an advance degree (MS or PhD) in these fields is highly preferred.

2. 5-7 years relevant industrial experience in the medical device field with expertise in biocompatibility and toxicology.

3. Fundamental understanding or direct experience with ISO 10993 standards, biomaterials, toxicological assessment, extractable and leachable analysis, medical device manufacturing processes, and biocompatibility assessment methodology.

4. Demonstrated proficiency in authoring biocompatibility risk assessments and the ability to independently design and implement effective testing strategies and protocols.

5. Must be team oriented and able to work well with diverse cross-functional teams and to interact in a professional manner with all organization levels.

6. Must possess strong analytical and process skills and be computer proficient.

7. Excellent technical writing ability, good organizational skills, project management skills and communication skills.


1. Bachelor of Science degree in toxicology, biomedical engineering, biological sciences or related field; an advance degree (MS or PhD) in these fields is highly preferred.

2. 5-7 years relevant industrial experience in the medical device field with expertise in biocompatibility and toxicology.