Kaleo Software

Software Engineer

• 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

Director, Development and Human Factor Engineering

Financial Planning and Analysis

• Serve as a strategic financial partner and the operational backbone of Kaléo’s Finance function
• Lead the annual budget, rolling forecast cycles, and long-range planning
• Develop integrated profit and loss (P&L), balance sheet, and cash flow models
• Prepare financial materials for the CEO, CFO, Board of Directors, and monthly Finance Committee reviews
• Provide financial oversight of the company’s revenue streams
• Lead a small Finance team and mentor team members
• Ensure effective internal controls and compliance with financial reporting requirements

Director, Development and Human Factor Engineering

Director, Finance