Senior Engineer - Cell Therapy- Medical device

About the Department                                                                                                                                     

Novo Nordisk, a global health care company, is committed to discovering and developing innovative medicines to help people living with diabetes lead longer, healthier lives. To support this, Novo Nordisk is conducting research on stem cell therapy. Stem cell research raises hopes for improved treatment of Type 1 Diabetes and for future treatments with cell transplantation therapy. This treatment could be offered to people with many different serious chronic diseases caused by the degeneration of specific cells, such as Type 1 Diabetes. Type 1 Diabetes is manifested by the selective destruction of the insulin-producing cells in the body, which leads to a life-long dependence on insulin injections to control blood sugar levels. It is usually diagnosed in children and young adults. Cell therapy may offer a better treatment by replacing the lost cells with new insulin-producing cells derived from stem cells, thus avoiding daily multiple insulin injections as well as numerous blood glucose tests. This treatment may also offer better blood glucose control, which is crucial to avoid late-stage complications such as blindness and kidney failure. In this project Novo Nordisk will generate new stem cell lines to be used in future cell therapies to treat Type 1 Diabetes, Parkinson’s and chronical heart failure.  Are you ready to make a difference?

The Position

The Sr. Engineer will design, develop, test and implement medical devices and device systems to prepare and administer advanced cell therapeutics.  By providing subject matter expertise to product development teams for medical device and biologic/device combination products, the engineer will enable safe and effective translation of these novel technologies into clinical trials and commercialization.  May informally supervise more junior personnel.

Relationships

Reports to a leader in Cell Therapy Medical Devices. Interacts with key company personnel both within and outside of Novo Nordisk as related to product development programs. Develops and maintains positive rapport and working relationships with other personnel in Cell Therapy R&D, and other partner departments within Novo Nordisk in support of initiatives and to accomplish company goals. 

Essential Functions

• Lead and work within cross-functional teams to develop new medical device designs to solve a wide range of technical challenges.  Develop devices considered combination products in conjunction with cellular medicines and related formulations.
• Lead the definition and development of user needs, business needs, use cases and requirements.
• Lead the planning and execution of user evaluations in lab-based surgical environments or other formative evaluation events to gain insightful feedback on system concepts. 
• Writes, reviews and approves protocols, executes protocols, performs analyses and writes, reviews and approves reports for R&D purposes, and compliant with Design Controls as part of formal Design Verification & Validation.
• Develop and lead verification and validation activities to ensure that product designs meet the customer needs, including bench testing, model/fixture development, ex vivo and/or in vivo testing as appropriate. 
• Advances medical devices from concept through to clinical implementation using Design Control processes preparing product designs for commercialization. 
• Prepare documentation to support Design Reviews at respective design control milestones. 
• Demonstrates a thorough knowledge of medical device development compliant with requirements for Europe (MDR, ISO 13495) and the USA (QSR / 21 CFR Part 820).  This includes phased development processes including Concept and Feasibility, Design Inputs, Design Outputs, Design Verification & Validation, Transfer to Manufacturing, etc.  
• Work with KOL’s (typically surgeons and interventionalists) to collect and synthesize customer inputs
• Explore new technologies, examine possibilities for diverse product solutions.  <