Senior Engineer - R&D - Medical Device, Microfluidics

About the Department

In Cell Therapy Research and Development, we are focused on developing cellular medicines that have the potential to change the way doctors treat intractable diseases. We manufacture targeted cell types derived from pluripotent stem cells using precisely controlled expansion and differentiation processes. Therapeutic areas of current focus include cardiomyocytes to treat heart failure, beta cells for diabetes, dopaminergic neurons for Parkinson’s disease and multiple cell types for dry age-related macular degeneration.

Join a dynamic, innovative and interdisciplinary team focused on developing the medical devices and combination products that enable preparation and delivery of these novel cell products. We develop micro and macro fluidic formulation and cell product handling devices, as well as a broad range of administration applications including devices for stereotactic brain delivery, beating heart delivery, general surgical implantation, etc.

The Position

The Senior Engineer – Research and Development – Medical Device, Microfliudics 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

• Ensure that product designs are manufacturable and cost-effective utilizing Design For Manufacturability principles.
• Support design transfer to manufacturing.
• Design devices, assemblies and components using Computer Assisted Design tools to create 3D models, drawings and manufacturing instructions
• 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.
• As required, design/develop and/or coordinate with 3rd parties to design/develop product packaging and labeling systems.
• Advances medical devices from concept through to clinical implementation using Design Control processes preparing product designs for commercialization.
• 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.
• Lead the definition and development of user needs, business needs, use cases and requirements.
• Guide and mentor junior R&D staff as required.
• 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
• Utilizes Geometric Dimensioning & Tolerancing techniques to ensure accurate and unambiguous documentation of product designs. Performs tolerance stack-ups.
• 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.
• Authors technical sections of regulatory submissions under guidance of Regulatory Affairs
• Establish and maintain partnerships with external suppliers, development partners, and other vendors as project requires.
• Prepare documentation to support Design Reviews at respective design control milestones.
• Work with KOL’s (typically surgeons and interventionalists) to collect and synthesize customer inputs
• 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.
• 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.
• Source materials, products and services from 3rd parties.
• 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.
• 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.
• 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
• Explore new technologies, examine possibilities for diverse product solutions.

Physical Requirements

0-10% overnight travel required.

Qualifications

• Detail oriented with strong documentation skills
• Experience mentoring junior employees.
• Preparation and management of Design History Files or equivalent
• Preferred experience includes subject matter preferred experience:
  • Experience with combination product medical product development.
  • Development of microfluidic systems designed to handle cell solutions
  • Experience managing collaborations, contracts and partnerships with external industry groups. Demonstrated success managing academic and clinical partners.
  • Experience mentoring junior employees.
  • Strong track record of designing medical devices, successfully translating concepts to clinical implementation
  • Highly proficient utilizing design and development tools including CAD systems
  • Solid functional knowledge of the statistics of quality as applied to medical device development
  • Strong understanding of design for manufacturability
• Experience with combination product medical product development.
• Bachelor’s degree, Master’s degree, or PhD is preferred. Degree in a relevant engineering field preferred
  • A Bachelor’s degree with 5+ years’ relevant experience, or Master’s degree with 3+ years’ relevant experience, or PhD with 0 years of experience can be considered
• A Bachelor’s degree with 5+ years’ relevant experience, or Master’s degree with 3+ years’ relevant experience, or PhD with 0 years of experience can be considered
• Ability to influence, communicate, and collaborate in teams spanning multiple time zones as part of a global organization
• Strong understanding of design for manufacturability
• Excellent written and oral communication skills
• Development of class II or class III medical devices.
• Solid functional knowledge of the statistics of quality as applied to medical device development
• Solid experience in product development, especially under Design Controls and for Design Verification & Validation
• Highly proficient utilizing design and development tools including CAD systems
• Demonstrated success developing microfluidic-based point-of-use systems
• Familiarity with medical device standards (e.g. IEC 60601, ISO 10993, ISO 14971, IEC 62366)
• High School Diploma required with minimum of 8+ years relevant experience required.
• Experience working with Design Controls systems compliant with ISO 13485, MDR, 21 CFR 820 and other relevant regulations
• Experience managing collaborations, contracts and partnerships with external industry groups. Demonstrated success managing academic and clinical partners.
• Development of microfluidic systems designed to handle cell solutions
• Relevant experience includes:
  • Development of class II or class III medical devices.
  • Solid experience in product development, especially under Design Controls and for Design Verification & Validation
  • Demonstrated success developing microfluidic-based point-of-use systems
  • 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
• Strong track record of designing medical devices, successfully translating concepts to clinical implementation
• Demonstrated ability to work independently, in teams, and with external collaboration partners

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. In addition, this position is part of the Annual Performance Incentive Plan. The role may also be eligible for a long-term incentive bonus depending on level and other Company factors.

Novo Nordisk requires all new hires to be fully vaccinated against COVID-19 prior to the first date of employment. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation.

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.