Lead Systems Engineer
Found in: Talent DK C2 - 3 weeks ago
Are you passionate about improving the lives of people living with chronic diseases? Do you have experience in developing connected medical devices? We are looking for a Lead Systems Engineer to join our Connected Solutions & Integration team at Novo Nordisk. If you are ready to drive innovation and make a difference, read on and apply today for a life-changing career.
The Position
Novo Nordisk is pursuing an ambitious strategy of improving the lives of people living with chronic diseases and driving business growth by innovating and launching connected medical devices and digital health systems.
As our new Lead Systems Engineer for connected medical devices, you will drive the design and development of our connected delivery solutions where you will interface with cross-functional teams, experts from across engineering disciplines, program managers, and global development teams.
The main tasks will include:
• Leading technical collaboration with internal and external stakeholders on connected medical device projects, leveraging systems engineering methodology and expertise.
• Driving trade-off discussions and ensuring technical alignment across project teams for one or more connected delivery solutions projects.
• Contributing to engineering processes related to connected medical devices and providing technical leadership and mentoring to project and development teams.
• Ensuring adherence to system architecture, design, and device development processes and standards.
• Ensuring compliance with relevant standards and regulations (e.g., IEC 62304, MDCG, FDA guidelines) and applying appropriate rigor and documentation for the classification of connected delivery solutions.
• Staying updated on the latest technologies, trends, and regulations in the connected medical devices domain to identify opportunities for innovation and improvement.
Qualifications
To be considered for this position, we expect you to:
Hold a Master or PhD degree within relevant field e.g., software engineering, electronic engineering, biomedical engineering, applied physics etc. Minimum 5 years of work experience in product development and Systems Engineering principles in the context of medical devices.It would be great advantage if you have the following:
INCOSE Systems Engineering Professional (SEP) certification ASEP, and preferably CSEP. Experience with Technical Project Management in regulated environment. Experience with operating under Medical Devices Design Control FDA 21 CFR 820, FDA Guidance for Content of Premarket Submissions for Device Software FunctionsA successful candidate will demonstrate excellent communication, negotiation, and problem-solving skills, as well as an ability to bring clarity to complex situations. You should feel motivated by enabling data-driven decision-making in a complex stakeholder landscape. Valuing teamwork, being self-motivated, and effectively managing your work schedule and project milestones are essential qualities. Being a team player, self-driven, and adept at navigating organizational complexity are also important attributes.
About the department
You will join the Connected Solutions & Integration team which is part of the broader Devices & Delivery Solutions (DDS) area responsible for developing the delivery solutions and serving different therapy areas. We are a diverse team of experts working on Novo Nordisk's connected device portfolio. Our colleagues, including project managers, solution architects, and subject matter specialists collaborate across Novo Nordisk to drive innovation and excellence in connected delivery solutions.
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