Director, ECD Development

📋 Description

• Own the execution of the technical strategy and phase-gated process of development, design
• Ensure rigorous compliance with applicable FDA Class III (PMA) design and development requirements
• Take ownership of the analytical performance strategy (limit of blank/detection, precision
• Contribute to the robust transfer of assays to the commercial laboratory and manufacturing in
• Partner with clinical and biostatistics leaders on statistical analysis plans required for
• Think team by partnering directly across bioinformatics, biostatistics, software engineering

🎯 Requirements

• Advanced degree (PhD, MD, or equivalent) in Molecular Biology, Biomedical Engineering, Life
• 6+ years of experience in IVD or diagnostic device development under design controls
• 5+ years of experience directing scientific or technical teams

🎁 Benefits

• Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and
• Free testing for employees and their immediate families
• Fertility care benefits
• Pregnancy and baby bonding leave
• 401k benefits
• Commuter benefits