Director, Development and Human Factor Engineering

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🕒 Maio 27

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Kaleo Software

SiteLinkedInTodas as Vagas

11 - 50 funcionários

💰 $7.000.000 Series A em 2015-10

As informações de que os funcionários precisam para realizar seus trabalhos são difíceis de encontrar. Estão espalhadas por sistemas, documentos e na mente dos colegas. Entendemos quão difícil é conseguir o que você precisa, e estamos aqui para ajudar. A Kaleo transforma automaticamente documentos e especialistas em FAQs pesquisáveis, de modo que encontrar qualquer coisa seja tão fácil quanto pedir por ela. Em vez de criar ‘mais um lugar’ para encontrar respostas, a Kaleo se integra a aplicações empresariais populares como SharePoint, ServiceNow e Slack para fornecer informações quando e onde os funcionários precisam delas.

Descrição

• 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

🎯 Requisitos

• 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)

🏖️ Benefícios

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