About the job
Do you want to play a key role in developing a new device portfolio from the ground up and can you contribute with solid experience within requirements, specifications, risk management and design control, then this is the perfect opportunity for you. Lundbeck has several development projects in pipeline requiring devices/combination products. We have just started our journey with implementing a fit-for-purpose QMS and setting the pillars for the future device (combination product) development and management within Lundbeck. This position provides a unique and rare opportunity of being part of something new and shaping the future.
As Device Senior Specialist (System Engineer) the main criteria of success are to establish, review and maintain project documentation (requirements, specifications, risk analysis etc.) ensuring safe and robust products to our patients. You will be a natural part of the project teams focusing on the device constituent of the combination product. You will also be an instrumental part of developing our device organisation and our working procedures (QMS) in parallel with executing project activities. You will work in close collaboration with colleagues across the organisation (CMC, QA, RA, Supply Chain and Commercial etc.).
The role is based in HQ (Copenhagen) but frequent business travels to partners in Asia, Europe and United States is to be expected (estimated 20-30 travel days per year).
Our new System Engineer will be an instrumental part of setting the direction for devices in Lundbeck and you have a rare opportunity to be part of the journey from the very beginning and you are guaranteed influence on the direction and setup.
In Lundbeck, we strive to develop new innovating treatments to improve the lives of patients suffering from brain diseases. CMC support the development and production of new drug candidates for diseases like Migraine, Parkinson’s disease and Alzheimer's disease. Established CMC focus teams and working groups are responsible for the continued development of Lundbeck's drug candidates and are working into global project teams with representatives from R&D, Preclinical and Clinical Development, Regulatory Affairs, and Commercial.
CMC is a global unit working with global CMO's. We are +80 colleagues split between Lundbeck Headquarters in Copenhagen and Lundbeck Seattle Biopharmaceuticals.
Your job and key responsibilities
- Develop and shape our (combination product) QMS in cooperation with your immediate colleagues
- Scope project deliverables and set the direction
- Manage the technical interface between Lundbeck and device partner
- Manage internal technical alignment between the device and drug constituents
- Implement and secure appropriate Design Control
- Drive, establish and maintain product requirements, specifications and risk manage files
- Drive verification planning and review design verification documentation
- Support Human Factor Studies
- Manage design reviews and design transfers (Lundbeck/CMO and between CMOs)
- Generate documentation for submissions
Our preferred candidate:
- 10+ years of experience working with device and combination products
- Masters or other advanced degree in a scientific background e.g. Master of Science, or equivalent
- Proven knowledge and understanding of device and combination product regulations (MDR, 21 CFR Part 4, 21 CFR 820/210/211 etc.)
- Proven knowledge and understanding of device and combination product standards
- (e.g. ISO 13485, ISO 11608-series, ISO 14971, IEC 62366-1 etc.)
- Extensive experience in device development and manufacturing
- Extensive experience in design control
- Pragmatic and flexible to design fit for purpose solutions
- A curios problem solver, willing to learn and develop
- Strong collaboration skills and ability to understand the agendas in Commercial, RA, QA and Product Supply
- A positive minded personality with flair for execution and keeping stakeholders engaged
- Manages ambiguity and thrives in a dynamic and changing environment
For further information, please contact Director of Device Development & Management, Michael Torben Pedersen at (+45) 29445851.
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Please click on the link below to apply for the job.
Applications will be reviewed ongoingly and must be received no later than October 24, 2021.
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