System Engineer

About the Department
Imagine transforming the face of biomedical research and building world-class protein technology platforms in a state-of-the art facility. That’s what we do at Novo Nordisk Research Center Seattle, Inc. (NNRCSI). Our scientists apply cutting-edge technologies to early discovery projects within the diabetes and obesity areas, with the goal of bringing molecules to market. Such projects include identifying protein-based therapies for obesity, diabetes, and adjacent therapeutic areas, and researching the next generation of medical devices. At the 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 in 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 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, generous benefits, 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 relevant 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.


Relationships
The Systems Engineer reports to a USDR Senior Project Manager. Internal relationships include Research & Development (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 will mostly be managed by more senior Systems Engineers, but occasionally relationships with commercial collaboration partners, academia, and NNRCSI drug researchers may be included.


Essential Functions
The Systems Engineer is expected to:

• 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
• 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.
• With general guidance, support team in the generation and maturing of relevant ideas and concepts, and in engineering and developing digital health and digital therapeutic products
• With general guidance, support team in making new, relevant inventions and ensure these are covered in new Novo Nordisk patent applications
• With general guidance, support team in maturing and developing products to be prepared for milestones A-C according to Device R&D project manual, for submission under Novo Nordisk’s SaMD procedure, or developed to a level that would supportpilot studies per relevant guidelines
• Occasionally participate in network with external collaboration partners; e.g. development partners, vendors, suppliers, etc.

Physical Requirements
Approximately 10% overnight travel.


Qualifications

• Bachelor’s degree with a minimum of 5+ years’ experience in product development, including at least 1 year in a regulated industry (e.g. medical devices, pharmaceuticals, military, etc.). Advanced degree may be substituted for experience, as appropriate
• Experience with processes related to medical device systems engineering: risk management, requirement engineering, specification writing, etc.
• 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
• Excellent written and oral communication skills
• Ability to influence, communicate, and collaborate across the local organization
• 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 devicespreferred
• Expected to be experienced and skilled in ‘creative innovation type of work’ as e.g. the Stanford ‘Design Thinking’ approach to innovation
• Knowledge of or experience with software development principles and tools (e.g. agile development, Scrum, Jira, etc.)

Novo Nordisk is an Equal Opportunity Employer /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.

Requisition ID: 59063BR
State/Provinces: Seattle
Job Category: Research