Senior Engineer
3 weeks ago
Novo Nordisk, a global healthcare 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, which raises hopes for improved treatment of Type 1 Diabetes and future treatments with cell transplantation therapy.
The PositionThe 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.
Responsibilities- 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.
- Write, review, and approve protocols, execute protocols, perform analyses, and write, review, and approve 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.
- Advance 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.
- Demonstrate a thorough knowledge of medical device development compliant with requirements for Europe (MDR, ISO 13495) and the USA (QSR / 21 CFR Part 820).
- Bachelor's degree required, Master's degree or PhD preferred.
- 5+ years of development of class II or class III medical devices.
- Solid experience in product development, especially under Design Controls and for Design Verification & Validation.
- Experience working with Design Controls systems compliant with ISO 13485, MDR, 21 CFR 820, and other relevant regulations.
- Familiarity with medical device standards (e.g. IEC 60601, ISO 10993, ISO 14971, IEC 62366).
- Preparation and management of Design History Files or equivalent.
- Experience with combination product medical product development.
- Experience with microfluidics and electromechanical systems.
- Experience designing parts for precision machining and injection molding.
- Experience managing collaborations, contracts, and partnerships with external industry groups.
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