Design Engineer

This is a fully remote position, open to applicants in United States.

📋 Description

• Generate innovative product concepts utilizing Computer-Aided-Design (CAD) software for designing concepts and prototypes.

• Collaborate with the development team and a seasoned product designer to explore new delivery methods.

• Create prototypes for evaluation and conduct product testing during the design phase to identify and resolve potential issues.

• Work together with external consultants and contract research organizations (CROs).

• Implement Design for Manufacturing (DFM) principles to facilitate the transition of devices from development to production.

• Collaborate with the Documentation Specialist on Design Controls for new drug/device initiatives.

• Contribute to the enhancement of Kaléo’s intellectual property portfolio.

• Oversee project and program budgets and timelines.

• Develop safe and effective pharmaceutical drug-delivery products in conjunction with the device development team and external partners.

• Assist in the creation of new drug-delivery platforms and the expansion of Kaléo’s platform offerings.

⛳️ Requirements

• Bachelor’s, Master’s, or PhD in Mechanical Engineering or a related discipline.

• Over 5 years of experience in product design, encompassing concept development, design, tolerance stacking, product development, prototyping, and test method development.

• Proficient in design software, including SolidWorks CAD.

• Experience in user-centric product design and development from previous positions.

• Previous experience in managing external Contract Manufacturing Organizations (CMOs).

• Familiarity with Computer-Aided Engineering (CAE) and Finite Element Analysis is preferred.

• A proven track record of accomplishments is preferred, such as granted US patents, device concepts from inception to launch, or approved or marketed products.

• Strong engineering design capabilities utilizing SolidWorks CAD software.

• Experience with 3D modeling software and report writing tools.

• Solid understanding of the fundamentals in Science, Engineering, and Technology.

• Analytical insight into complex mechanical design principles.

• Capability to present confidently to both external and internal stakeholders.

• Ability to collaborate with and supervise external CROs.

• Capacity to work independently and manage projects effectively.

• Dedication to fostering and maintaining an inclusive work environment.

🏝️ Benefits

• Annual bonus.

• Comprehensive benefits package.

• Remote-first culture with the flexibility to choose a domestic work location.

• Occasional travel, estimated to be less than 25%.