Engineer - R&D, Medical Device

Facility:  Engineering
Location: 

Fremont, CA, US

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 Engineer - R&D, Medical Device will make significant contributions to the research of life changing medical devices at Novo Nordisk. They leverage their strong background in engineering to perform their individual tasks as well as energetically engaging in collaborative work. The Engineer I- R&D, Medical Device will contribute to insert subject matter expertise. They ensure strong progress on research initiatives under the broad direction of more senior engineers and management. May hire at a higher level commensurate with experience.

 

Relationships

The Engineer - R&D, Medical Device reports to the head of the relevant engineering team. Internal relationships include fellow engineers, data scientists, anthropologists, software developers, technology scouts & partnership developers, designers, medical doctors, IT professionals, and others across US and Denmark. External relationships include commercial and academic collaboration partners.

 

Essential Functions

  • 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
  • Writes and reviews protocols, executes protocols, performs analyses and writes and reviews reports for R&D purposes, and compliant with Design Controls as part of formal Design Verification & Validation
  • Supports advancement of medical devices from concept through to clinical implementation using Design Control processes preparing product designs for commercialization
  • Demonstrates a working 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.
  • Utilizes 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. Perform root cause and failure analyses, identify and implement design, material and process mitigations
  • Source materials, products and services from 3rd parties. Coordinate services and projects with 3rd party providers including CMO’s
  • Utilize a basic understanding of Design for Manufacturability principles so that product designs are manufacturable and cost-effective
  • Support design transfer to manufacturing ensuring that products satisfy their intended use
  • Utilizes Geometric Dimensioning & Tolerancing techniques to ensure accurate and unambiguous documentation of product designs. Performs tolerance stack-ups
  • Responsible for authoring and reviewing Design Control documentation including, but not limited to, design requirements, trace matrices, risk management documents, specifications, standard operating procedures
  • Authors technical portions of regulatory submissions under guidance of Regulatory Affairs

 

Physical Requirements

0-10% overnight travel required.

 

Qualifications

  • Bachelor's degree preferred. Minimum of High School diploma required. Degree within relevant engineering field preferred
  • Bachelor’s degree with 0-1+ years’ relevant experience can be considered or HS with 4+ years relevant experience required
  • Relevant experience includes:
    • Experience in development of class II or class III medical devices
    • 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)
  • Preferred experience includes:
    • Familiarity with combination product medical product development
    • Demonstrated experience designing medical devices, successfully translating concepts to clinical implementation
    • Proficient utilizing design and development tools including CAD systems
    • Understanding and functional knowledge of the statistics of quality as applied to medical device development
    • Demonstrated understanding of design for manufacturability
    • Knowledge and experience utilizing risk assessment and mitigation tools and techniques
  • Knowledge and/or professional experience is preferred in the pharmaceutical industry, healthcare industry, regulated medical device development, or another regulated field
  • Demonstrated ability to work independently and in teams
  • Excellent written and oral communication skills
  • Detail oriented with strong documentation skills

 

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.

 

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.