Advisor – Drug Delivery Device Development

Role Summary

Advisor – Drug Delivery Device Development

Responsibilities

• Partner with Therapeutic Areas and Discovery groups to anticipate needs and define requirements.
• Lead the development of system-level solutions to stakeholder needs; map and execute technical strategy
• Collaborate with scientists and engineers to define requirements for medical devices and combination products.
• Create and test prototypes for injection devices; identify, develop and evaluate internal and external technologies that may address stakeholder needs; assist in developing best practices and processes for technology assessment.
• Partner with best-in-class CROs for preclinical testing - lead/contribute to protocol design, plan, schedule and execute studies, analyze and interpret results and communicate to relevant stakeholders.
• Participate in, lead and/or manage cross-functional teams, providing technical input, guidance, mentorship, and performance feedback.
• Develop/train junior team members as needed.
• Partner with internal and external stakeholders as needed

Qualifications

• BS in engineering or a related field; advanced degree preferred.
• Minimum 7 years of experience in technical leadership or similar roles
• Minimum 5 years of experience in concept generation, designing, prototyping, developing, analyzing and integrating electromechanical systems
• Excellent communicator and collaborator with both technical and non-technical stakeholders.
• Excellent analytical and problem-solving skills, with the ability to find innovative solutions to complex technical challenges.
• Expert user of Mechanical and/or Electrical CAD, e.g. SolidWorks, Altium, or equivalent.
• Proficient in scripting (LabVIEW, Python, MATLAB etc.) for data acquisition, instrument control and data analysis.
• Proficiency in design controls and quality systems in a regulated industry.
• Working knowledge of software and hardware development methodologies, technologies, and best practices.
• Ability to thrive in a fast-paced, dynamic environment and effectively manage competing priorities.
• Proficiency in predictable project execution frameworks and tools, such as Agile, Scrum, or Kanban is preferred.
• A track record of successfully leading and managing cross-functional teams in agile development environments is preferred.

Skills

• Product development and systems engineering
• Prototype development and testing
• Cross-functional team leadership
• Technical communication and stakeholder management
• Regulated industry quality systems
• Software and hardware development methodologies
• Agile, Scrum, or Kanban project execution

Education

• BS in engineering or related field; advanced degree preferred.