Our company’s Device Product & Process Development Team designs, develops, and commercializes novel biologic/drug/vaccine-device enabled combination products to achieve safe and effective delivery to their intended site of action
Job Summary
Our company’s Device Product & Process Development Team designs, develops, and commercializes novel biologic/drug/vaccine-device enabled combination products to achieve safe and effective delivery to their intended site of action.
This position will lead cross-functional development teams and set tactical and strategic direction on programs to ensure high quality products and robust manufacturing processes.
The successful candidate will be eligible for annual bonus and long-term incentive, and we offer a comprehensive package of benefits including medical, dental, vision, retirement, paid holidays, and vacation.
Matching Summary
Our company’s Device Product & Process Development Team designs, develops, and commercializes novel biologic/drug/vaccine-device enabled combination products to achieve safe and effective delivery to their intended site of action.
Salary
Base: $153,800.00 - $242,200.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Medical, dental, vision, retirement, paid holidays, vacation
Skills & Requirements
Must-have
Device development strategy leadership
Combination product development
Cross-functional team leadership
Regulatory submission and approval
Design controls and risk management
Manufacturing process development
Medical device quality systems
Nice-to-have
Strategic thinker and influencer
Excellent communication and negotiation
Experience with automation and injection molding
Knowledge of global medical device regulations
Ability to work independently
Proactive problem resolution
Hybrid work environment
Key Requirements
B.A./B.S in Engineering
Minimum 10 years medical device and combination product experience
5+ years leadership in device and product development
Knowledge of FDA and global medical device regulations