Beschreibung
Device Verification Engineer
Randstad Professionals is actively looking for:
Device Verification Engineer
Group Responsibilities:
Evaluation, selection, design, development, characterization, interaction and industrialization of medical devices for combination products (eg, pre-filled syringe, needle safety device, auto injector, injector pen, infusion pump, new technology, special packaging)
Application to; and integration with; parenteral drug products for development, clinical, handling study use and for first commercialization as required by the R&D portfolio, considering required regulatory, legislative, ecological, economical and technical aspects -
Evaluation of new and breakthrough technologies
Drive towards optimum use of platform technologies, in alignment with key stakeholders
Specific Responsibilities:
Evaluation, characterization and verification of medical devices for combination products and primary container (eg, pre-filled syringe, vials, cartridges, new technology, special packaging)
Practical evaluation of new and breakthrough technologies
Development of new test methods
Implementation of new lab testing equipment
Generation of plans, protocols, reports as required
Organize experimental, development, Verification, complaint investigation and change evaluation testing
Liaison with; and provide technical support to; key customers in clinical and commercial phases - such as filling, assembly and packaging operations, packaging and quality groups, regulatory, process and formulation development groups, supply chain
Support to Technology Transfer of combination products and medical devices into commercial facilities/packaging centers
Requirements:
Technical education, preferably with an engineering degree
2-5 year track record and experience in practical testing and characterization of medical
device, special/innovative packaging, or in development sector specializing in compact, complex, multi-material hand-held products
Experience of working in pharma or other closely-regulated environment, under cGxP, QSR or similar working practices
Sound knowledge of legislation, regulation, industry standards and guidance around the area of combination products and medical devices
Demonstrable practical knowledge of the following:
Drug container integrity o
Parenteral drug delivery (eg: sub-cutaneous, intra-venous, intra-muscular, transdermal)
Statistical Techniques
Jigs and Fixtures design, Instrument Calibration, Equipment qualification
Functional testing and reliability
Risk Assessment o Primary packaging
Material science
Excellent documentation skills
Excellent team player, with collaborative and oral/interpersonal/communication skill
Excellent IT knowledge
Excellent command of spoken/written German and English
You feel you could take this next challenge in your career? Don't hesitate to send your application.
Good to know you!
Please note that only candidates who are a close match will be contacted regarding this role; non EU/EFTA Citizens cannot be considered.