Job Summary

• Support assembly process development for medical devices and/or combination products, including accessorized prefilled syringes, auto-injectors, and other devices.
• Provide technical leadership in a fill-finish/assembly pilot laboratory, develop risk assessment tools, and ensure technical rigor in experimental design and data analysis.
• Assist or lead late-stage and commercial design transfer of assembly processes to CMOs and internal facilities, managing timelines and cross-functional teams.

Matching Summary

Salary

Base: $79,336.80 - $119,005.20 USD Annual; Bonus/Equity: Short-term incentive bonus opportunity, equity-based long-term incentive program; Benefits: Qualified retirement program (401(k) plan), paid vacation and holidays, paid leaves, health benefits (medical, prescription drug, dental, vision)

Skills & Requirements

Key Requirements

• Bachelors degree and 5+ years med device experience
• Master's degree and 2+ years med device experience
• Experience with combination products and cGMP regulations
• Experience with assembly, label and packaging processes
• Experience with validation of equipment and processes
• Experience with QbD, experimental design, statistics, data analysis
• Experience with design transfer or leading multi-functional teams

Work Rights