Biocompatibility Expert

Position Summary:

The Biocompatibility Expert will develop the initial draft of biocompatibility related projects to safeguard global health. This will include obtaining all necessary information from the client and performing the necessary literature research. This information will then be summarized in a technical format for the project and submitted for peer review. They will also assist with peer review as needed.

Education and experience requirements:

• Bachelor's degree in a relevant science with 5 years' relevant experience or an MS/PhD degree in a biocompatibility related emphasis

• Strong understanding and ability to apply biocompatibility principles preferred

• Medical device industry experience

• FDA/NB interaction a plus

• Scientific degrees in the following areas are highly desired: Biology, Chemistry, Cellular Biology, Molecular Biology, Anatomy/Physiology

• Participation in AAMI/ISO working groups

• Fully authored >20 risk assessments

• Collaboration in a team setting

Essential Duties:

Consulting

• During initial assessment draft, work cross-functionally with other departments to guide where biocompatibility expertise is necessary

• Write and review Biocompatibility Assessments and other biocompatibility related documents as needed (i.e. Opinion Memos for patient safety)

• Discuss approaches to evaluation strategies with peers to ascertain good alignment within team

• Communicate with the client to obtain additional information for projects or biocompatibility related testing

• Perform literature research on materials and compounds

• Build and implement process improvements

• Know and follow the Nelson service standard

Regulatory Compliance

• Follow applicable regulatory requirements (GMP, GLP, ISO, etc.).

• Follow company policies and procedures.

Competencies of this position

• Good project management skills

• Demonstrated strong writing skills (samples of writing should be provided)

• Strong verbal communication expertise

• Previous experience in performing biological evaluation and applying risk-based approach preferred

• Excellent communication skills

• Excellent technical writing skills and expertise

• Attention to detail

• Time management - must be able to respond to voicemails, emails and other communications in a timely manner

• Able to multi-task and be self-motivated

• Knowledge Microsoft Office applications (Word, Excel, PowerPoint, Outlook, etc.)

Work Environment:

This job operates in a professional office and laboratory environment. This role routinely uses standard office equipment such as computers and phones. Typically works in an office environment but may occasionally be required to perform job duties outside of the typical office setting.

Travel requirements:

Occasional travel during the business day. Some out-of-the area and overnight travel may be expected. May be required to attend domestic and international trade shows, seminars and conferences.

Physical requirements:

Must be able to stand/walk for 10% of the day and 90% of the day sitting at a desk or on the computer. Must be able to occasionally lift a maximum of 45lbs.