Join our Device Product & Process Development Team focused on innovative biologic/drug/vaccine-device combination products for safe and effective delivery
Job Summary
Join our Device Product & Process Development Team focused on innovative biologic/drug/vaccine-device combination products for safe and effective delivery.
Lead and execute design verification strategies, including test method development, aging studies, and validation activities to support clinical and commercial approvals.
We offer a comprehensive benefits package including medical, dental, vision, retirement plans, paid holidays, vacation, and bonuses.
Matching Summary
Join our Device Product & Process Development Team focused on innovative biologic/drug/vaccine-device combination products for safe and effective delivery.
Salary
Base: $142,400.00 - $224,100.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Medical, dental, vision, retirement, paid holidays, vacation
Skills & Requirements
Must-have
Combination product design verification
Design verification test methodologies
Cross-functional team collaboration
Regulatory submissions for combination products
Drug and device product development
Design control and risk management
Test method development and validation
Nice-to-have
Analytical and numerical simulation experience
3D CAD and rapid manufacturing techniques
Strong interpersonal and strategic thinking skills
Experience with compression/tensile testing and rheology
Lab capability gap identification and training
Excellent communication and project management
Knowledge sharing and professional development
Key Requirements
B.S. in Mechanical Engineering + 8 years experience
M.S. in Mechanical Engineering + 5 years experience
Ph.D. in Mechanical Engineering + 3 years experience
Leadership in combination product design verification
Strong knowledge of regulatory standards and requirements
Experience with design controls and risk management