Systems Engineer in Product Maintenance
- Denmark - Hillerød
Would you like to have a direct impact on people’s lives by ensuring the reliability of Novo Nordisk’s insulin pens and other medical devices? Do you think that navigating in a complex and controlled environment with strict regulatory requirements, whilst ensuring world-class productivity and product quality, is an interesting challenge? Then you might be our new Systems Engineer in Product Maintenance.
About the department
The position is located in the Design Controls team in the Product Maintenance department. Product Maintenance holds the design responsibility for Novo Nordisk’s medical devices after the device design has been transferred from R&D to production. The Design controls team consists of 12 skilled engineers with in-depth understanding of the design control process as well as technical expertise within mechanics, electronics, software and materials. Each team member is responsible for one or more marketed products e.g. our high quality insulin pens.
As Systems Engineer for the NovoPen product family, you will be a key person in the life cycle of Novo Nordisk portfolio of re-usable insulin pens. It is your responsibility to ensure that the products fulfil the defined requirements and that safety risks are identified and mitigated. You fully understand the interface between mechanics, hardware and software and can navigate within each area as well as in the interfaces. You own the technical product documentation and are responsible for maintaining a high quality technical file which must be ready for audits and inspections at all times.
Working in Product Maintenance is a great opportunity to use your systems engineering skills in a context close to the market. You will on a daily basis be involved in production challenges, design change requests, customer complaint handling and regulatory submission activities. The tasks shift from urgent expert input in a task force setting to independent, longer term strategic work to improve the product and its technical documentation. Working together with other specialists all around Novo Nordisk, there is much opportunity to further develop your skills, both in-depth and cross-functional.
The position also contains an opportunity to influence the work processes surrounding systems engineering, risk management and design controls in the post-launch phase.
You have an academic degree in a relevant engineering field. Your possess 5+ years of experience within the development or manufacturing of medical devices or other products where quality and regulatory compliance are vital to succeed. You have a strong technical understanding and have documented experience with products involving many disciplines. Experience with software validation and IEC 62304 is an asset. You will work in an international environment, hence solid skills in written and spoken English is a must.
Strong personal dedication, integrity and networking skills are needed to set direction and make decisions in a complex stakeholder environment, often with diverging interests. You are well-structured and have a systematic way of working, seeking simple and effective solutions within the complexity that surrounds a medical device and its documentation package.
Working at Novo Nordisk
At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development.
For further information, please contact Linda Nilsson at +45 3075 0872.
28 February 2018.
Please note that we will invite candidates for interviews continuously throughout the posting period.
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