We have an excellent job opportunity available as a Principal Scientist/Engineer Biological Assessments!
Our role is expected to last 1 year.
Remote
We 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
Requirements of the Principal Scientist/Engineer:
- 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
Please be advised- If anyone reaches out to you about an open position connected with Eliassen Group, please confirm that they have an Eliassen.com email address and never provide personal or financial information to anyone who is not clearly associated with Eliassen Group. If you have any indication of fraudulent activity, please contact InfoSec@eliassen.com.
Job ID: 376087
About EG Life Sciences:
Founded in 2010, EG Life Sciences is a national professional services firm that delivers strategic consulting and innovative solutions for the pharmaceutical, biologic, medical device, and diagnostic industries. We provide tailored services to clients seeking to manage challenges, improve time-to-market, and fine-tune clinical development and operations. Our team is comprised of dedicated professionals and FDA-regulated industry specialists, each averaging over 20 years of related experience. This combination of services and team members enables us to quickly deliver value-driven life sciences consulting, project management and leadership, and customized project-based solutions.
Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
Don’t miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!
