Mechanical Design Engineer

About the role

This is a remote opportunity with occasional travel (estimated at less than 25%). At Kaléo, we passionately pursue meaningful and innovative solutions for patients, believing everyone should have access to innovative healthcare products that empower fuller, bolder lives. Kaleo is developing pharmaceutical drug delivery programs with commercialization opportunities to follow. The Mechanical Design Engineer will work with the device development team and external collaborators to create safe, effective products on‑time and on‑budget, helping to build new drug‑delivery platforms and expand the existing Kaleo portfolio.

Responsibilities

• 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 with over 200 patents 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 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

• Bachelors, Masters, or PhD in Mechanical Engineering or a related field.
• 5+ years of experience in product design, including concept development, design, tolerance stacking, product development, prototyping and test method development.
• Proficient in design software (e.g., SolidWorks CAD).
• User‑centric product design and development experience from previous roles.
• Past exposure to managing external CMOs.

Qualifications

• 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).

Skills

• Strong engineering design skills using SolidWorks CAD.
• 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.

Pay

The anticipated base salary range for this position is $90,000 to $120,000. Final compensation will be determined based on factors including experience, education, skills, and geographic location. This position is also eligible for an annual bonus and comprehensive benefits.