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stillingsbetegnelse: Senior Engineer – design control and compliance

jobbeskrivelse:

Can you help us take our medical device area to the next level?

If you have experience within design control of medical devices and you are looking for a job with great variety in tasks as well as the opportunity to put your personal mark on LEO Pharma’s way forward, this is it. As part of our Injection Devices engineering team you will focus on design control and risk management across existing and new products to ensure compliance.

 

Optimise, build and manage systems for compliant design control and risk management

As Senior Engineer your overall objective is to contribute to LEO’s goal of becoming the world’s preferred dermatology care partner. You will do so by further developing and managing our set up for maintenance of marketed Injection Device products. You will be the one to make input and deliverables from multiple stakeholders come together via the right processes and your additional coordination. You will:

• Ensure compliance of documentation for marketed Injection Devices products 
• Build new processes and systems to implement new products and ensure compliance
• Review documentation from external partners and adjust to match our set up
• Adjust and optimise documentation to ensure compliance
• Be part of various cross organisational forums as Injections Devices’ compliance expert

You can look forward to a coordinating role with contacts across the global LEO organisation and to external partners and suppliers. Additionally, you will have ample opportunities to influence the shaping of your own role as well as our total set up.

 

Medical device experience and understanding of high volume production

You have an engineering degree and some years’ experience from working with medical devices. This has provided you with a good understanding of design control and risk management in a high volume production set up – and the additional ability to tailor processes to ensure compliance and one way of working across multiple sites and departments. Related to this, you understand input from different stakeholders, and you can generate a common understanding of direction and guidelines across sites and partners.

Since the medical device area is still new in LEO it is very important that you can thrive in an environment where we do not have a fully developed set of SOP’s. As such, you must be able to make decisions and choose the right way forward based on the information at hand. At the same time you must be a team player that likes to acquire and share knowledge.

 

Injection devices – your new team

You will join 7 skilled and highly motivated colleagues in Injection Devices based at LEO Pharma’s HQ in Ballerup. Our responsibility covers product solutions across medical devices, drug-device combination products and device constituent parts from early ideation until transfer to commercial manufacturers. The ambition is to grow as LEO Pharma is developing and expanding the presence in the injectable biologics area. We also support the long marketed Innohep® product against thrombosis.

We work as a team and share a passion for breaking new land in an environment characterised by helpfulness, knowledge sharing and collaboration.

 

Contact and deadline

Contact: Niels Gudiksen, Phone: 3167 6830
Deadline: 11 November 2018

We look forward to receiving your application. 

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2141

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: LEO PHARMA A/S

source: DK-STAR