System Engineer

Found in: beBee S DK - 3 weeks ago

Hillerød, Denmark Novo Nordisk AS - 20K Full time

Are you ready to play a key role in Novo Nordisk’s delivery solutions innovation and help improve patient outcomes? Do you want to use your engineering background to conceptualize the next generation of medical devices for a variety of chronic diseases? If so, then we encourage you to apply today to become our new Systems Engineer

The Position

As our new Systems Engineer, you will play a key role in materializing user, business and technological opportunities into solid engineered medical device concepts that can be developed and brought to the hands of patients. Working on the early stages of the product lifecycle, you will be responsible for accurately translating stakeholder requirements into system requirements as early concepting starts and evolves. This will require you to keep a holistic and structured view of the various requirements while managing interdisciplinary challenges that occur during that process. You will work in close collaboration with multiple stakeholders (e.g., commercial, medical and science, CMC, regulatory affairs, risk managers, mechanical engineers, software and hardware engineers, project managers, development manufacturing, UX, and designers) and you will play an important role in connecting these stakeholders across professional areas of expertise.

Your main responsibilities will include:

Establish stakeholder needs and system requirements, ensuring alignment with project goals and regulatory standards. Prepare for design control during early concept development, facilitating the transition of system requirements to the development team. Develop Design Verification and Validation strategies, including clinical trials and Human Factors Engineering (HFE) assessments. Collaborate with the project team to assess the technical feasibility and risks of device platform concepts, conducting trade-off analyses for concept selection. Interact with various stakeholders to consolidate inputs and facilitate decision-making, driving project progress and success.

Utilize cross-disciplinary expertise within the department to inform assessments and address technical challenges effectively, conducting thorough analyses to identify and mitigate potential system or risk-related issues early in the development process.

Qualifications

You hold a bachelor's or master’s degree in biomedical engineering, mechanical engineering, materials engineering, or a similar field, and have a minimum of 2+ years of experience in R&D medical devices or in other regulated industry. You must be fluent in English (both written and spoken).

To succeed in this role, you should have experience in the following areas:

Design control processes and familiarity with industry standards and regulations such as ISO 13485, MDD or MDR, and Safety Risk Management, including ISO 14971. You should also be knowledgeable about Design Verification and Design Validation. Managing stakeholder needs and effectively translating them into system requirements, while collaborating with external academic and industry partners. Executing systems engineering technical processes as defined in ISO 15288 and applying robust design principles.

Additionally, having experience in the following areas would be advantageous:

Project management for internal and cross-functional improvement projects. Successfully overseeing a product from concept to product launch and demonstrating proficiency in requirements tools, e.g., Modern Requirements. Managing platforms and variants through Product Line Engineering, Configuration Management, and/or Variability Modeling, including experience with materials eengineering and sustainability.

As a person, you are curious, solution oriented, analytical, and structured, demonstrating attention to detail while keeping the overview of the system you are engineering. You thrive in a dynamic and changing environment and are not afraid of voicing your opinion and challenging the status quo on our processes. You are a strong team player recognized for your interpersonal skills. You bring a "can do" spirit, leading by example, and inspiring and motivating your colleagues.

About the Department

The Engineering department consists of highly skilled and motivated professionals and specialists which take pride in being the experts in driving innovation, by using a unique range of expertise (idea generation, conceptualization, rapid prototyping, and systems engineering) to materialize opportunities into solid engineered solutions. We are part of Novo Nordisk Device Delivery Solutions, which is the organization responsible for the R&D of device solutions for medical self-treatment within all business areas of Novo Nordisk A/S.

In our department, we generate and manage a wide range of ideas and concepts, integrating voices of the customer, business, and technology to conceptualize robust systems that are ready for development execution. Our main aim is to advance projects that will improve the healthcare experience of people living with chronic diseases and their healthcare professionals, while fulfilling Novo Nordisk’s triple bottom line (social, environmental, and financial responsibility). You will join a dynamic, international, and innovative environment, where highly skilled professionals work closely together to develop the next generation of medical devices.

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