Director, Development and Human Factor Engineering

Kaleo Software

Director of Development and Human Factor Engineering at Kaléo, leading drug delivery devices’ development with a focus on human factor studies and design controls.

Posted 5/27/2026full-timeRemote • 🇺🇸 United StatesLeadWebsite

About the role

Key responsibilities & impact

Manage and execute the company’s Design Controls and Drug Development Program for drug/device combination product development in accordance with Kaleo’s Quality System and 21 CFR 820.30/ISO 13485
Lead and responsible for human factor engineering activities as per the regulatory guidelines
Work with design, development and manufacturing partners to ensure program execution for the development of Kaleo’s drug delivery devices stay on timeline and within approved budget
Execute Risk Management Programs and Analyses in accordance with Kaléo's Quality System. Utilize Risk Analyses tools including DFMEA, UFMEA and PFMEA in accordance with ISO14971:2019
Provide leadership for the new products in device design, development, industrialization, stability and pilot clinical activities, execution of design controls and development documentation activities
Help build Kaleo’s intellectual property portfolio
Manage project and program budgets and timelines effectively
Author and review regulatory submissions (as needed)
Responsible for reporting progress, risks, and opportunities to senior management on an ongoing basis to ensure good progress on all development portfolio programs

Requirements

What you’ll need

Bachelors, Masters, or PhD in a technical field related to Product Development or Industrialization (Biomedical Engineering, Mechanical Engineering, Material engineering, Systems Engineering preferred)
Patient centric drug/device combination product development experience
Minimum 10+ years of medical device development experience, with experience in managing external CMO’s
Experience in design controls, risk management and ISO 13485
Minimum 5+ years of managing human factor engineering studies (formative and summative)
Demonstrated record of accomplishments preferred (e.g., issued US patents, device concept to launch, approved drug/device combination products)

Benefits

Comp & perks

Remote opportunity with occasional travel, estimated at less than 25%

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

design controlsdrug/device combination product developmenthuman factor engineeringrisk managementDFMEAUFMEAPFMEAISO 13485ISO 14971:2019project management

Soft Skills

leadershipcommunicationorganizational skillsbudget managementtimeline management