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Medical Device Development Project LeaderRef: DT24234

Salary:€700 - €800 per day

Added:14 May 2019

Region: Europe

Sector: Pharmaceutical

Sub Sector: Clinical Research

Particularly relevant: * Thorough project planning * Provide primary packaging and device expertise in a broader cross-functional drug product development team * Leading Risk management activities * Planning and monitoring of design verification activities (in-house) * Leading and authoring technical documentation * Ensuring a high-quality Design History file * Transfer of Design History File to production Education (minimum): Bachelor's or Master degree in Packaging Science/Engineering or Mechanical Engineering or University level Engineering education. An ideal candidate would have a relevant degree in engineering and at least 7 years' experience in leading device development technical teams in a similar area Languages Required Fluency in English language is required. Desirable experience: Proficiency in German/French advantageous. Experience/Professional requirement: Particular relevant experience: * Understanding of medical device regulations (FDA 21CFR 820, FDA 21CFR Part 4, EU Medical Device Directive, EU Medical Device Regulation) * Development and writing of technical documentation of drug/device combination products and medical devices, including Design Control process and other applicable regulatory, QA and GMP aspects * Mechanical engineering in general o Test and verification, incl. development of methods and equipment * General understanding of Human Factors Engineering, risk management and clinical studies processes and requirements Desirable experience: * Mechanical engineering in general o Product design/Design for manufacture * Good understanding of pharmaceutical development in general * Experience in project / program management of complex projects * Considerable experience of managing external suppliers * Good communication and conflict solving skills

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