The Senior Bio Engineer requires broad and deep experience with all types of complex electrical/mechanical equipment used as pharmaceutical delivery systems, complex drug injectables, as well as electrical/mechanical extracorporeal blood treatment systems - spanning all clinical application settings including: NICU, PICU, Adult ICU, Anesthesia, Acute Care, Home and Transport. This experience is used extensively for device validation and qualification efforts critical to the labeled drug(s) indication.
In addition, the Senior Bio Engineer role assists with research in the hospital and medical transport environment. The role also provides key information to product support representatives within Mallinckrodt which allows them to understand the complexities of the following in relation to the products: Hospital policy/procedure, Air carrier policy/procedure, Medical transport policy/procedure, & FAA rules and regulations regarding medical transport.
The Senior Bio Engineer plays a key role in creation and review of many SOP’s and design process documents and specifically will own the Human Factors/Usability Engineering SOPs, WIs and associated templates. These documents require intensive clinical and field input. The Senior Bio Engineer role leads the collaboration for these key documents, (labeling, instructions for use, validation strategy/protocols, validation reports, and other reference materials), by closely coordinating with the US/EU field-based Clinical Specialists, Technical Services team, engineering teams and others to establish consensus on the documents prior to approval. This individual will also work closely with Quality and Manufacturing to ensure that processes are in place for all design activities.