The primary function of the Sr. Device Development Specialist is twofold: 1. Provide medical and usability input and representation at all cross-functional team meetings for assigned product(s), and 2. Coordinate study execution activities to include study design, protocol and report preparation. This position may support both serialized and non-serialized device development
MAJOR DUTIES AND RESPONSIBILITIES:
Provide Clinical input as requested
Review and approve protocols, test reports, risk analyses, and Labeling
Participate in usability testing, including authoring / co-authoring protocols and reports
Review specification documents for developing products and review data for 510(k) submissions
Provide clinical input (medical background and workflow knowledge) to cross-functional teams involved in the process of new product development and remediation, as requested by Operations,(Manufacturing plants, Tech Operations), Quality, Regulatory, and Marketing
Provide medical risk assessment as needed per SOP
Work with cross-functional team to create and update product documentation, including, but not limited to, User Needs document (UND), user interface requirements document (UIRD), use error risk analysis (UERA), system operating manual (SOM), TIPS cards, instructions for use (IFU) for disposables, etc.
Timely communication of study results, including formal and informal reports
Review and approve labeling designed for clinical use for assigned products
Interface with Marketing Managers for assigned products providing medical and clinical input as requested.
Develop and maintain effective working relationships with Research and Development (R & D) Engineering, Commercial Development, Regulatory Affairs, Quality, Marketing, and other departments in order to facilitate / encourage information exchange and successful product development and launch
Leverage clinical experience to provide ad hoc and preliminary ‘voice of the customer’ decisions regarding product design
Interface with Customers as requested to ensure clear understanding of user requirements / issues
Process on-market issues with potential user impact by reviewing events with manufacturing to ensure understanding of issue
Ensure that required clinical/medical documents are provided for regulatory submissions
A Bachelor's degree in Nursing is required along with a minimum of 5 years hospital inpatient experience working with IV pumps/sets. Previous industry experience is strongly preferred, preferably with medical devices along with knowledge and experience with FDA regulations and Device Standards.
Hospira helps hospitals heal the hurting. The company makes specialty injectable pharmaceuticals (primarily generics) including...