Kaleo Software

Mechanical Engineer

• Conceptualize new product ideas using Computer-Aided-Design (CAD) software to design concepts and prototypes
• Partner with the development team and an experienced product designer on new delivery concepts
• Fabricate prototypes for testing and test products throughout the design process to troubleshoot potential problems
• Collaborate with external consultants and contract research organizations (CROs)
• Apply Design for Manufacturing (DFM) principles to support transfer of devices from development into production
• Partner with the Documentation Specialist on Design Controls for new drug/device programs
• Help build Kaléo’s intellectual property portfolio
• Manage project and program budgets and timelines
• Develop safe, effective pharmaceutical drug-delivery products with the device development team and external collaborators
• Support creation of new drug-delivery platforms and expansion of Kaléo’s platform portfolio

Design Engineer

Medical Director

• Serve as a subject matter expert, translating clinical evidence, stakeholder insights, and emerging scientific developments into strategic Medical Affairs recommendations
• Develop and maintain compliant relationships with KTLs and external scientific experts
• Plan and conduct scientific exchanges, congress meetings, advisory boards, roundtables, consensus initiatives, and related engagements
• Develop KTL engagement plans, objectives, interaction plans, insight documentation, and follow-up
• Provide scientific coverage for national and selected regional congresses, including program assessment, session prioritization, coverage plans, KTL preparation, insight capture, and post-congress readouts
• Lead scientific execution of Medical Affairs booths, including educational strategy, content development, onsite scientific exchange, medical inquiry handling or routing, insight capture, and reporting
• Develop and maintain medical education materials, congress resources, presentations, standard response letters, FAQs, and other non-promotional communications
• Support publication planning, literature reviews, abstracts, posters, manuscripts, white papers, and publication governance review
• Conduct literature surveillance and synthesize scientific, clinical, safety, and competitive developments
• Aggregate and analyze insights to identify evidence gaps, educational needs, stakeholder barriers, and strategic opportunities
• Represent Medical Affairs on cross-functional teams and provide scientific expertise to Regulatory, Quality, Commercial, and other internal stakeholders
• Serve as trained backup for defined Pharmacovigilance, Medical Information, and Product Complaint activities
• Perform other duties consistent with the scope and level of the position

Design Engineer

Associate Director, Medical Affairs