Darum lohnt es sich
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 Website 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) #J-18808-Ljbffr
