The SR Manager Device Development & Technology is an Individual Contributer role, reporting to the Director/Associate Director of Device Development and Technology. This individual will be responsible for Program Management of Device Development. They will also be the technical expert in the field of combination products & drug delivery devices who can effectively navigate and balance complex engineering, regulatory, quality and commercial needs while developing the best product for the user and patient. Primary expertise should be demonstrated in engineering, device regulatory, device quality systems (CFR 820, ISO 13485), human factors engineering principals, risk management for medical devices (ISO 14971), etc. The successful candidate should demonstrate strong technical writing and presentation skills and be able to translate technical information to non-technical audiences. This position requires 7 - 10 years of applicable experience in the pharmaceutical, biotechnology or medical device industries.
The candidate will be responsible for the creation and management of design history files and technical dossiers for combination and device projects for new and existing products. Additional responsibilities include facilitation of risk assessments, coordination of human factors usability studies, creation and management of product and component specifications, design control documents, engineering protocols and reports and frequent presentations to project teams and management. This position will frequently require management of outside resources as well as assigned and/or unassigned leadership of project teams in a matrix organization. Technical Writing experience required.
The position may involve frequent domestic and international travel up to 10% or as required by the project. Will manage indirect reports.
Support the vision for the Device Development function
Develop and support the strategic activities of the department:
Develop and perform the tactical activities:
Program management of Device projects: