Mechanical Design Engineer

Kaléo develops innovative pharmaceutical drug delivery products and solutions for patients. The Mechanical Design Engineer will develop safe, effective drug delivery devices and platforms by designing and testing prototypes, applying design-for-manufacturing principles, collaborating with internal teams and external partners, and managing project budgets and timelines.

Responsibilities:

• Conceptualize new product ideas by using Computer-Aided-Design (CAD) software to design concepts and prototypes
• Partner with the development team and an experienced product designer with over 200 patents issued on new delivery concepts
• Fabricate prototypes for testing and test products throughout the design process to troubleshoot any potential problems
• Collaborate with external consultants and contract research organizations (CROs)
• Apply Design for Manufacturing (DFM) principles to support transfer of the device from development into production
• Partner with the Documentation Specialist on Design Controls for new drug/device programs
• Help build Kaleo’s intellectual property portfolio
• Manage project and program budgets and timelines effectively

Requirements:

• Strong engineering design skills using SolidWorks CAD software
• Experience with 3D modeling software and report writing programs
• Strong motivation and self-management skills with the ability to work independently
• Proven knowledge of the fundamentals in Science, Engineering and Technology
• Analytical approach to understanding and communicating complex mechanical design principles
• Excellent communication skills, including detail-oriented technical capabilities and the ability to present with confidence to external and internal partners
• Ability to collaborate with and manage external CROs
• Desire to serve as a technical resource and subject matter expert to cross-functional teams
• Strong drive to achieve results, make recommendations, and pursue continuous improvement
• Ability to work collaboratively, with the judgment to know when to escalate for support
• Commitment to participating in, and upholding, an inclusive work environment
• Bachelors, Masters, or PhD in Mechanical Engineering or in a related field
• 5+ years of experience in product design, including experience in concept development, design, tolerance stacking, product development, prototyping and test method development
• Proficient in design software (E.g. SolidWorks CAD) required
• User-centric product design and development experience from previous roles
• Past exposure to managing external CMOs
• Experience with Computer-Aided Engineering (CAE) and Finite Element Analysis
• Demonstrated record of accomplishments (e.g., issued US patents, device concept to launch, approved or marketed products)