Senior Systems Engineer with a quality mindset for Device R&D

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Hillerød

  • Engineering
  • Hillerød

Are you ambitious and motivated by bringing products to patients? Do you find it interesting to work with mid to late phases of our device development pipeline, and do you thrive on delivering high quality documentation in line with pharmaceutical medical device requirements? Then you may be the one we are looking for to join our Device Development team within Device R&D located in Hillerød.

About the department
As part of the Novo Nordisk Device R&D family, we make a real difference for patients with chronic diseases across the world by designing and developing the best and widely-used drug delivery devices. In the Device Development department, we work on mid to late phases of the medical device development pipeline. Our task is to ensure robust design of the existing development candidates so that they can be produced on a large scale for millions of patients. Moreover, we are responsible for generating high quality documentation to demonstrate compliance with health authorities’ regulations around the world. We are an interdisciplinary team of systems engineers, risk managers, mechanical engineers and project coordinators with backgrounds in both hardware, software and biomedical engineering. We work closely together on projects to deliver on time and at the right quality level, and we work in close collaboration with various stakeholders across Novo Nordisk, including Device Manufacturing Development (DMD), Regulatory Affairs (RA), Quality Assurance (QA), Marketing, Customer Complaints etc.

The position
As our new Senior Systems Engineer, you will become a member of one or more project teams, working from mid to late phases of our device development pipeline. In collaboration with your colleagues, you will drive system design by combining user insights, new innovations and regulatory requirements to advance the care of people living with chronical diseases all taking a point of departure in variations of already developed devices. This includes product specification/requirement engineering, risk analysis, tolerance stack-ups and material selection. At all stages, you will document your work to ensure compliance in line with pharmaceutical and medical device requirements, and you will work according to ISO standards and in a design control environment. In addition, we expect you to focus on improving processes and optimizing documentation in various projects to ensure alignment and reusing of design and development practices to essentially expand the medical device platform. In addition, your work may also involve mechanical component design, verification and validation - both in the lab and with end-users and you will participate in customer complaints investigation and change control processes.

Qualifications
You hold an academic degree within Engineering (e.g. Mechanical, biomedical or similar), where you have achieved great results. You have a minimum of 3 years of work experience within Systems Engineering. Work experience within medical device development and/or with design control processes for medical devices is considered an advantage.

As a person, you are comfortable with taking initiative and have a strong personal drive and dedication. You bring a good sense of humour to your work even when pressure is on, and you thrive in a changing and dynamic environment. You like to demonstrate attention to detail and you are structured in your problem-solving approach.

Proficiency in both oral and written English is essential.

Working at Novo Nordisk
By being patient-focused, we have achieved a market leading position and we continuously develop our expertise to stay ahead – both as a company and as individuals. Working here means joining a team of highly qualified, ambitious colleagues with a passion to bring better treatments to the people who need them.

Contact
For further information, please contact Matthew Clemente +45 3077 5862.

Deadline
July 6, 2020

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.


Information og data

Denne ledige stilling har jobtypen "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".

Arbejdsstedet er beliggende i Hillerød.

Jobbet er oprettet på vores service den 30.6.2020, men kan have været deaktiveret og genaktiveret igen.

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Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Afdelingsleder
  • Hillerød
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