Product Development Scientist

Job Summary

A company is looking for a Product Development Scientist to join their Interventional Oncology development team.

Key Responsibilities

• Support studies to characterize products and processes related to implantable intravascular therapies
• Design and conduct pre-clinical and analytical studies to assess new products and applications
• Collaborate with regulatory affairs teams to prepare submissions for FDA medical device processes

Required Qualifications and Education

• BS in Biology, Biomedical Engineering, or related field; MS or PhD preferred
• 3+ years of experience in scientific or engineering roles, preferably in medical devices
• Experience in the development and qualification of pre-clinical studies
• Familiarity with medical device regulatory and quality issues (FDA & ISO 13485)
• Working knowledge of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)