Mar 08, 2018
Apr 07, 2018
Valerio Celenza
Jobseeker Type
Organization Type
Clinical Practice
Contract Type
Full Time

My client, an innovative medical device start-up with legal office in northern Italy has an immediate need for a Preclinical Test Lab Manager.
Company is in strong growth - they are already FDA approved - and this position will offer a tremendous growth opportunity, as the management and executive structure is still in the formative stage.

The candidate will be responsible of the planning and execution of all testing activities required by international standards and MD regulatory directives for the preclinical evaluation of innovative implantable for the treatment of cardiovascular disease.

Duties and responsibilities:
* lead the execution of all numerical analyses and in-vitro/in-vivo investigations required by international standards for the preclinical evaluation of Company's prosthesis
* responsible of the daily operations of in-house labs, shall prove ability to manage multiple testing projects simultaneously
* collaborate con R&D resources for the design and development of specific new testing
* collaborate and manage external vendors, including contract research organisations and cross functional teams to ensure R&D project timelines are met
* write/approve test protocols and reports, out of specification (OOS) documents, technical summaries, procedures, and other pertinent deliverables
* lead and support continuous improvement initiatives by exploring alternate testing methods and developing new processes with focus on quality and regulatory compliance

* B.S. or Master degree in Mechanical Engineering, Biomedical Engineering, or related disciplines
* Minimum of five (5) years of related experience in cardiovascular medical device testing and/or product development
* Experience in preclinical testing as per ISO 5840
* Experience in cardiovascular medical products is highly preferred
* Experience in Class III medical product development involving clinical studies
* Fluency in English is mandatory

The position is based in Northern Italy (relocation assistance is negotiable).
Availability to travel, even for long periods, is mandatory

Interested? Get in touch!

For a confidential discussion, or to apply, send your CV to me,

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