Director, Combination Product Development and Human Factor Engineering

This is a remote opportunity with occasional travel, estimated at less than 25%. Kaléo is a global leader in drug‑delivery device technology and auto‑injector innovation, providing millions of patients, government partners, and emergency responders with security and peace of mind. The Director, Combination Product Development and Human Factor Engineering is responsible for managing the development of new combination products including design, development, and human factor studies through design transfer into manufacturing. The individual should be involved in building Kaleo's intellectual property portfolio development. The Director will support the senior leadership team with critical information to make informed decisions on the selection of key partners, risks, and identification of critical milestones (budgeting, R&D build strategy, etc). This individual will need to develop strong relationships with external partners to ensure completion of all aspects of device/drug development and support of Human Factor studies from planning to execution. Internal interactions with Business Development, Manufacturing, and Regulatory Affairs provide opportunities to expand knowledge and make an impact on business development and post marketing activities. Key relationships to this position include Regulatory Affairs, External Partners (Suppliers, CMO and CDMO), Legal, Supply Chain, and Manufacturing. As Director, Combination Product Development and Human Factor Engineering you will:

• 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

A successful Director, Combination Product Development and Human Factor Engineering will demonstrate:

• Self-motivated and confident with excellent personnel management skills, organizational skills, analytical abilities, and problem-solving techniques
• Strong technical abilities while being an effective leader
• Must demonstrate initiative, exercise good judgment, and have the ability to achieve results through others
• Strong analytical skills with the ability to creatively solve complex problems
• Excellent verbal and written communication skills when interacting with internal stakeholders at all levels of the organization and external partners, facilitating strong working relationships
• Focused attention to detail
• Ability to work collaboratively and cross-functionally when opportunity arises while holding the team to high standards of excellence
• Display a tenacity to move major initiatives forward with a focused effort and clear set of business goals
• Adept at integrating input from various functional areas and bringing people together to achieve results

To be considered for this position, you must have:

• 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)

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