Principal Scientist/Engineer, Biological Assessments, Med Device

Principal Scientist/Engineer, Biological Assessments, Med Device

BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTION

Our Fortune 500 medical device client designs, develops, manufactures and markets orthopedics products for implantable or prosthetic devices, in more than 25 countries. This particular client is a world leader in musculoskeletal health solutions.

The right consultant be responsible for planning, organizing and conducting biological safety risk assessments on medical devices in accordance with current regulations.

DUTIES / EXPECTATIONS OF THIS ROLE

· 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

MUST HAVES - QUALIFICATION SUMMARY

1. Working Knowledge of analytical chemistry.

2. Minimum educational requirement is a MS in relevant scientific disciplines, such as biology, chemistry, biomedical engineering, and/or toxicology.

3. Minimum of 8 years of experience for Senior II level or 10 years of experience for Principal level in medical device research (Orthopaedic industry preferred) or an equivalent combination of PhD, Postdoctoral, and experience in related field required.

4. Minimum of 4 years of experience conducting Biological Safety Assessments per ISO 10993

5. Has strong understanding of ISO and 10993 standards and EU MDR.

6. Prior experience with risk assessment of manufacturing materials.

7. Strong interpersonal skills and experience in training others.

8. Excellent oral and written communication.

9. Demonstrates the ability to discuss sensitive information with a tailored approach to management, surgeons, and external contracts.

TRAVEL & LOCATION

REMOTE

START & TERM

ASAP, contract through the end of 2023 with high probability of extension

*Eliassen Group provides medical dental and 401K during the time of your engagement*