Medical Device Technical Expert

For our client on BASEL we are looking for a MEDICAL DEVICE TECHNICAL EXPERT for a 6-MONTH contract.

DURATION: ASAP TO 31/01/2019 (EXTENSION PLANNED)

LOCATION: BASEL

WORKLOAD: 90% - 100%

REQUIREMENTS:

An ideal candidate would have a relevant degree in engineering and at least 5 years of experience in a similar area, including:
. Pre-filled-syringe device development, from early phase activities up to commercialization and production scale-up;
. Medical device quality assurance;
. DHF compilation, including Design Control process and other applicable regulatory, QA and GMP aspects;
. Understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive);
. Background in mechanical engineering in general
. Product design/Design for manufacture
. Test and verification, incl. development of methods and equipment
. Experience in medical device quality assurance;
. Good communication and conflict solving skills;
. Good technical knowledge in primary containers, eg syringes and cartridges;
. General understanding of pharmaceutical development;
. General understanding of Human Factors Engineering and Risk management. 

MAIN TASKS:
. Ensure product compliance for the assigned projects
. Compile Design Control documentation and contributing to a high quality Design History file.
. Establishes/Participates in the documentation strategy
. Support of development of Quality Assurance Agreements with third parties.

For further details please contact Beata Arciszewska:
email(see below)
tel