Director, Combination Product Development and Human Factors Engineering

Responsibilities

• 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

• 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)

Qualifications

A successful Director, Combination Product Development and Human Factors 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