Mechanical Design Engineer

At Kaléo, our way is not to seek to be like others, but rather to passionately pursue meaningful and innovative solutions for patients. We believe all people should have access to the innovative healthcare products and solutions that empower each of them to live fuller, bolder lives.

Kaleo is pursuing development programs for pharmaceutical drug delivery, with commercialization opportunities to follow. The Mechanical Design Engineer will play a critical role in the successful execution of these development programs by working with the device development team and external collaborators to develop safe, effective products on-time and on-budget. This position will play a key role in the creation of new drug delivery platforms in addition to expanding the current Kaleo platform portfolio.

If you are a creative thinker with user-centric product design and development experience in the industry, this is an exciting opportunity to work on life-transforming products while operating remotely. The collaborative team setting will provide you with learning support while still fostering a high degree of autonomy and responsibility in your area of expertise. Kaleo's "remote-first" culture will offer you the flexibility to choose your work location domestically, placing an emphasis on self-management and adherence to deadlines.

As the Mechanical Design Engineer, you will:

• 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.

• 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 preferred.
• Demonstrated record of accomplishments preferred (e.g., issued US patents, device concept to launch, approved or marketed products).