Technical Project Lead, Combination Product Development

Kindeva Drug Delivery Careers - Germantown, MD

Full-time - Mid Level

Germantown, MD

About the position

The Technical Project Lead for Combination Product Development at Kindeva Drug Delivery is responsible for leading the development of drug delivery devices, particularly autoinjectors. This role involves providing technical leadership and expertise throughout the product lifecycle, ensuring compliance with regulations, and collaborating with various teams to deliver market-ready combination products. The position requires a hands-on approach to project management, engineering, and design optimization, with a focus on delivering high-quality solutions to improve patient outcomes.

Responsibilities

• Lead the technical development of devices and combination products.
• Collaborate with internal departments and external vendors to deliver combination product projects according to goals, timelines, and budgets.
• Communicate effectively with senior leadership, project teams, customers, and suppliers.
• Use visual management techniques to communicate project strategy, risks, and status.
• Provide engineering expertise to support cross-functional teams in defining and executing device and combination product process development and technology transfer activities.
• Responsible for Design History Files, Risk Analysis, FMEA, Device Master Records, Specifications, etc.
• Lead feasibility assessments, including prototyping, analysis, and lab testing.
• Perform first principles analysis and modeling of key performance attributes of devices.
• Champion DFSS and CPD&M methodologies.
• Lead technical risk management activities and manage change controls for new or improved designs.
• Develop project schedules using MS Project and SmartSheet.
• Establish and maintain an understanding of current trends and emerging technologies in combination products.

Requirements

• A minimum of 7 years of pharmaceutical, device, and/or diagnostics development experience.
• BS required, MS preferred in engineering or relevant technical discipline such as biomedical, mechanical, or chemical/biochemical engineering.
• Experience in the development of autoinjectors, pre-filled syringes, or other combination drug delivery devices.
• Experience with Combination Product regulations and analytical chemistry.
• Strong knowledge of prefilled syringe and autoinjector technical standards (e.g., ISO 13485, ISO 11608, ISO 14971).
• Ability to work on-site in Germantown, MD.
• Ability to do domestic and some international travel (up to 30%).

Nice-to-haves

• PMP certification
• Experience developing drug delivery devices for emergency use
• Experience developing drug delivery devices for military and/or first responder applications
• Expertise in Design for Six Sigma and CPDM methodologies
• Experience using SolidWorks

Benefits

• Competitive salary
• Health insurance
• 401k plan
• Paid time off
• Professional development opportunities