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.
• Oversees risk management activities including development of Risk Management Files. Implements and coordinates Risk Analyses, Failure Modes and Effects Analyses, Fault Tree, Fishbone Diagrams and similar risk assessment and management tools
• Acts as technical subject matter expert for design and development of medical devices representing Medical Device R&D on cross-functional teams including product development teams
• As required, design/develop and/or coordinate with 3rd parties to design/develop product packaging and labeling systems.
• Design devices, assemblies and components using Computer Assisted Design tools to create 3D models, drawings and manufacturing instructions. Build prototypes, perform feasibility testing and evaluate designs.
• Manage 3rd party design, development and manufacturing partners (CDMO's, CMO's) to advance medical device designs from concept to clinical and commercial use. Coordinate design, development and manufacturing with CDMO/CMO's.
• Guide and mentor junior R&D staff as required.
• Establish and maintain partnerships with external suppliers, development partners, and other vendors as project requires.
• Source materials, products and services from 3rd parties.
• Ensure that product designs are manufacturable and cost-effective utilizing Design For Manufacturability principles.
• Support design transfer to manufacturing.
• Utilizes Geometric Dimensioning & Tolerancing techniques to ensure accurate and unambiguous documentation of product designs. Performs tolerance stack-ups.
• Responsible for creating and managing Design History Files. Authors, reviews and approves Design Control documentation including, but not limited to, design requirements, trace matrices, risk management documents, specifications, standard operating procedures.
• Authors technical sections of regulatory submissions under guidance of Regulatory Affairs

Physical Requirements
UP to 10% overnight travel required.
Qualifications

• Bachelor's degree required, Master's degree, or PhD is preferred. Degree within relevant engineering preferred
  • Bachelor's degree with 5+ years' relevant experience, or Master's Degree with 3+ years' relevant experience
• Relevant experience includes:
  • 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
• Preferred experience includes:
  • 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.
• Strong track record of designing medical devices, successfully translating concepts to clinical implementation
• Highly proficient utilizing design and development tools including Solidworks
• Solid functional knowledge of the statistics of quality as applied to medical device development. Familiarity with JMP preferred.
• Strong understanding of design for manufacturability
• Thorough understanding of risk assessment, management and mitigation strategies, tools and techniques to ensure positive risk/benefit determinations.
• Ability to establish sound working relationships.
• High initiative with the ability to work independently.
• Detail & deadline oriented; well organized.
• Flexible. Demonstrated ability to rapidly adjust to shifting priorities.
• Excellent verbal and written communication skills. Able to communicate complex technical subjects to non-technical personnel.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. The base compensation range for this position is $98,820 to $172,000. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.
Novo Nordisk offers long-term incentive compensation depending on the position's level or other company factors.
Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.