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Systems Engineer III - Digital Therapeutics

Facility:  Information Technology & Telecom
Location: 

Seattle, WA, US

Imagine transforming the face of biomedical research, helping patients getting healthier with digital therapeutics, and advanced medical devices in a state-of-the-art research facility. That’s what we do at Novo Nordisk Research Center Seattle, Inc. (NNRCSI). Our scientists and engineers apply cutting-edge technologies to early R&D projects with the goal of bringing real change to People with Diabetes and Obesity. Such projects include applying data science when developing advanced medical devices and digital decision support solutions. At NNRCSI, your skills, dedication and ambition will help us change lives for the better. In exchange, we’ll offer you an opportunity to work with extraordinary talent, continuously learn and develop, and drive change to defeat diabetes and other serious chronic conditions.

 

The team is comprised of collaborative, diverse and passionate people who have a true sense of pride in their work and are committed to helping others grow and develop their careers. You’ll also have a platform to engage with key stakeholders on a global scale throughout the entire pipeline process. And while changing the future of diabetes and obesity treatment is no easy task, we also recognize the importance of an enjoyable workplace, which is why we’ve cultivated a culture of fun, ingenuity and innovation. And our competitive compensation package and support of a healthy work-life balance all add to a best-in-class employee experience. We are changing lives for a living. Are you ready to make a difference?

 

The Position
The USDR Systems Engineer will contribute as a team member to the USDR vision to explore and develop new technology, product ideas, and game-changers that may hold the potential to add value to patients and Novo Nordisk in the future within therapeutic areas covered by Novo Nordisk corporate strategy. The Systems Engineer will apply deep engineering knowledge and skills to mature concepts and develop prototypes and products in digital health and digital therapeutics, and to generate robust design documentation packages. Engineering skills are needed to design attractive products that balance satisfying user needs with innovative technical solutions and business potential according to Novo Nordisk corporate strategy. The Systems Engineer will be part of a development team and contribute to development of digital health and digital therapeutic solutions as a team member and will act as a mentor to other team members.


Relationships
The Systems Engineer reports to a USDR Senior Project Manager. Internal relationships include R&D colleagues within USDR and Device R&D colleagues in Denmark. This includes peer R&D Engineers, Data Scientists, Software Engineers, and others, including specialists in the Device Innovation Support (DIS) area. External relationships include commercial collaboration partners, academia, and NNRCSI Seattle drug researchers. May also be assigned responsibility for relation to external collaboration partners, and/or students.


Essential Functions

  • Be responsible for establishment of user and product requirements
  • Be responsible for design verification and design validation activities in Software as Medical Device (SaMD) development projects
  • Establish Product Profile (PP), System Functions Analysis (SFA), Product Specification (PS), and other applicable documents to document design process
  • Plan and report design Verification and design Validation activities
  • Compile milestone documentation packages
  • Understand and apply relevant standards to the development process
  • Be a champion of the product vision and assist in steering project to correct end state through knowledge, experience, stakeholder engagement, and organic leadership
  • Ensure relevant engineering knowledge and skills are up-to-date, e.g. methods and tools within software engineering, mathematics, requirements engineering, risk management, good documentation practices, product development, etc.
  • Regularly contribute to the generation and maturing of relevant ideas and concepts, and in engineering and developing digital health and digital therapeutic products
  • Regularly contribute to new, relevant inventions and ensure these are covered in new Novo Nordisk patent applications
  • Regularly contribute to maturing and developing products to be prepared for milestones A-C according to Device R&D project manual, for submission under Novo Nordisks SaMD procedure, or developed to a level that would support pilot studies per relevant guidelines
  • Support the development and maintenance of a network of external collaboration partners; e.g. development partners, vendors, suppliers, etc.


Physical Requirements
0-10% overnight travel required.


Qualifications

  • Bachelor’s degree required; Master’s degree preferred. Advanced degree may be substituted for experience, as appropriate
  • 8+ years of experience in product development, including at least 3 years in a regulated industry (e.g. medical devices, pharmaceuticals, military, etc.)
  • Experience from development of medical devices preferred
  • Demonstrated ability to generate valuable and relevant ideas, create concepts based on ideas, and develop new products based on concepts
  • Ability to work independently as well as working in teams. Included in this is the ability to network with external parties
  • Expected to be knowledgeable and skilled in creative innovation; e.g. Stanford Design Thinking approach to innovation
  • Excellent written and oral communication skills required
  • Ability to influence, communicate, and collaborate across the global organization
  • Deep knowledge of at least one of these processes related to medical device development: risk management, requirement engineering, test method development, design verification, design validation, etc.
  • Experience from development of medical devices preferred
  • Experience with software development principles and tools (e.g. agile development, Scrum, Jira, etc.)
  • Experience in developing software classified as medical device (SaMD), Certified Scrum Master preferred

 

Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

 

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.