This is a primarily remote position and is open to remote applicants.

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.

Kaléo is pursuing development programs with pharmaceutical companies, with commercialization opportunities to follow. The Design Engineer will play a critical role in the successful execution of these development programs by working with the Director of Engineering and external collaborators to develop safe, effective products on-time and on-budget. The Design Engineer will play a key role in the management of external partners and collaboration with pharmaceutical partners in the delivery of these programs.

If you are a detail-oriented engineer with product development experience in the medical device industry, this is an exciting opportunity to work on life-transforming products while operating within a deadline-focused remote environment with clear objectives and milestones. 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. Kaléo’s “remote-first” hybrid culture will offer you the flexibility to choose your work location, placing an emphasis on self-management and adherence to deadlines. At Kaléo, you can feel confident that your work has a tangible impact on the lives of patients.

As Design Engineer you will:

Conceptualize new product ideas by using Computer-Aided-Design (CAD) software to design prototypes.
Partner with the Director of Engineering, a key original member of the Kaléo team with over 200 patents issued during his tenure at the company 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.
Support the Manager, Development Engineering and VP, Development with key project deliverables.
Support internal and regulatory inspections.

A successful Design Engineer will have:

Strong engineering design skills using SolidWorks CAD software.
Experience with 3D modeling software and report writing programs.
Adherence to risk-averse and compliant engineering documentation development and management criteria.
Strong motivation and self-management skills with the ability to work independently.
Analytical approach to understanding and communicating complex mechanical design principles.
Excellent communication skills, including detail-oriented technical writing capabilities and the ability to present with confidence to external and internal partners.
Excellent ability to collaborate and manage external CROs.
Ability to collaborate with legal on drafting and reviewing program-related contracts.
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.

To be considered for the position, you must have:

Bachelor’s Degree in an engineering discipline.
3+ years of experience in the medical device industry, including experience in the SolidWorks CAD program (3D CAD, 2D Drawings, and TolAnalyst), product development, test method development and execution.
Proficiency in Word, Excel, PowerPoint, and statistical analysis software (JMP, Minitab, etc.).
Working knowledge of 21 CFR 820.
Working knowledge of the ISO 11608 series.
Ability to travel overnight up to 15%.

Additional preferred qualifications:

Mechanical, Biomedical, Chemical engineering degree preferred.
Medical device development experience, specifically auto-injector products, strongly preferred.
Experience in Predicative 6-Sigma Design and Critical Parameter Development & Management (CPD&M) preferred.
Preferred certifications/memberships: Six Sigma, International Organization for Standardization (ISO), Professional Engineer (PE) certification, American Society of Mechanical Engineers (ASME), Society of Plastics Engineers (SPE).

Please complete candidate application for consideration. Additional questions can be directed to talentacquisition@kaleo.com.