Vacancy expired!
We have an excellent job opportunity available as a Principal Scientist/Engineer Biological Assessments!
Our role is expected to last 1 year.RemoteWe can facilitate w2 and corp-to-corp consultants. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance. Responsibilities of the Principal Scientist/Engineer:- Resource for biological evaluation of changes to current manufacturing processes as well as new manufacturing processes for new product development
- Biological Safety Risk Assessments and development of testing strategies for medical devices
- Resource for remediation of the biological evaluation of existing product to new regulatory requirements
- Internal technical document creation and approval
- Support complaints investigations, CAPAs, and other general technical support duties required within the team
- Create Technical Reviews, specifications, and other mandatory documents for regulatory submissions
- Review and preparation of procedures to keep pace with standards development
- Represent the company via presentations to groups of experts, societies, regulatory bodies and at international meetings
- Help to develop and generate material for staff training and data presentations
- Maintain relevant scientific and medical knowledge by attending conferences, courses, and meetings
- Educate internal colleagues across departments and divisions in the area of biological safety evaluations, risk assessments, and chemical characterization
- Provides support for key opinion leaders
- MS in relevant scientific disciplines, such as biology, chemistry, biomedical engineering, and/or toxicology
- 8+ years of experience for Senior II level or 10 years of principal level in medical device research
- 4+ years of experience conducting Biological Safety Assessments per ISO 10993
- Strong understanding of ISO and 10993 standards and EU MDR
- Experience with risk assessment of manufacturing materials
- Strong interpersonal skills and experience in training others
- Excellent oral and written communication
- Working knowledge of analytical chemistry