Associate Principal Engineer, Drug-Device Combination Products

Requirements

• Develop detailed plans and strategies for combination of product assembly process and equipment development
• Lead technical team to deliver a qualified process and equipment for clinical or commercial use
• Design and author Process validation activity and documentation like IQ, OQ, PPQ etc.
• Author protocols, reports, create drawings and specifications to ensure proper documentation of development activities in accordance with relevant SOPs
• Experience in designing automated combination product assembly equipment and experience in managing equipment suppliers
• Experience in developing, implementing and troubleshooting combination product assembly equipment processes including vision systems, ultrasonic welding and automated component and glass feeding and handling systems
• Experience and the ability to manage all aspects of manufacturing site readiness including equipment qualification requirements and all associated documentation
• Understanding of device and combination product DFM/DFA principles and design and failure modes in relation to assembly processes
• Excellent oral and written communication skills and the ability to present complex information in a clear and concise manner to partner group stakeholders
• Mechanical aptitude and hands-on troubleshooting skills, with the ability to work independently in a laboratory setting and manufacturing floor setting
• Strong interpersonal skills with an ability to collaborate in a team environment
• High level work ethic

Benefits

• Medical, dental, vision healthcare and other insurance benefits (for employee and family)
• Retirement benefits, including 401(k)
• Paid holidays, vacation, and compassionate and sick days