Director, Development and Human Factor Engineering

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

📋 Description

• Oversee and implement the company's Design Controls and Drug Development Program for the advancement of drug/device combination products, adhering to Kaleo’s Quality System and 21 CFR 820.30/ISO 13485 standards.

• Lead and take responsibility for human factors engineering initiatives in accordance with regulatory guidelines.

• Collaborate with design, development, and manufacturing partners to ensure that the execution of Kaleo’s drug delivery devices development adheres to timelines and approved budgets.

• Implement Risk Management Programs and Analyses in line with Kaléo's Quality System, utilizing Risk Analysis tools such as DFMEA, UFMEA, and PFMEA in accordance with ISO14971:2019.

• Provide leadership for new products in device design, development, industrialization, stability, and pilot clinical activities, including the execution of design controls and development documentation tasks.

• Contribute to the growth of Kaleo’s intellectual property portfolio.

• Effectively manage project and program budgets and timelines.

• Draft and review regulatory submissions as necessary.

• Responsible for regularly updating senior management on progress, risks, and opportunities, ensuring positive advancement on all development portfolio programs.

⛳️ Requirements

• Bachelor's, Master's, or PhD in a technical discipline related to Product Development or Industrialization (Biomedical Engineering, Mechanical Engineering, Material Engineering, Systems Engineering preferred).

• Experience in patient-centric drug/device combination product development.

• At least 10 years of medical device development experience, including management of external CMOs.

• Proficiency in design controls, risk management, and ISO 13485 standards.

• A minimum of 5 years of experience managing human factors engineering studies (both formative and summative).

• A demonstrated track record of achievements is preferred (e.g., issued US patents, device concept to launch, approved drug/device combination products).

🏝️ Benefits

• Remote work opportunity with occasional travel, estimated to be less than 25%.