Director, Development and Human Factor Engineering

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Kaleo Software

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11 - 50 employés

💰 €7 000 000 Series A en 2015-10

description traduite de l'entreprise

Description

• 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

🎯 Exigences

• 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)

🏖️ Avantages

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