Engineer – Validation and Documentation Specialist

1 mese fa


Palermo, Italia Neoolife A tempo pieno
About the Company:

Neoolife is a pioneering startup (US-based with a presence in Europe) backed by a multinational leader in structural heart disease treatment. Our mission is centered around innovating polymeric heart valve technologies. Our primary focus is the development of an advanced polymeric heart valve using a transcatheter platform. Position Overview:

As Engineer of Validation and Documentation at Neoolife, you will primarily focus on the Validation process (release test plan, test execution in cooperation with the R&D team, and Test Report summary) inside the validation and standardization of processes for the development of cardiac tissue engineering of our laboratories based in Palermo. The position will also proactively cooperate with QMS implementation and management and requires a minimum of knowledge in the medical device field, possibly with the use of electrospinning, biofabrication systems, and biomechanics. The Engineer will be part of the R&D team and report directly to the Vice President of R&D. Essential requirements: Bachelor’s Degree or equivalent experience in medical device or pharmaceutical manufacturing

or other related field of study; Has worked with and understands ISO 13485 or FDA CFR820: experience and knowledge of the applicable medical device standards or pharma industries will be considered as a strong plus; Displays creative and original thinking Should have up-to-date knowledge of the quality system requirements, practices, and procedures. The candidate must possess good technical writing ability and strong communication and presentation skills in English; speaking

Italian is a plus but not mandatory. Profound understanding of Microsoft Office (Word and Excel). Desirable: Biofabrication (e.g., electrodeposition, 3D printing); Tissue engineering scaffold design and fabrication; Basic notions of durability and hydrodynamic assessment and native tissue mechanics; Maintain technical documentation; Teamwork, sense of initiative, flexibility Target-oriented and problem-solving Generates suggestions for improving work

and critical thinking Language skills Excellent knowledge of the English language – written and spoken Location The primar y location will be Palermo (Italy), and it will mainly require a full-time on-site employee. The document release phase can be managed remotely from home. Next Steps If a match is found upon receiving your application , the Recruiting team will contact you for an initial HR interview. If there's a positive match, a technical interview with the Sector managers will be arranged. I f the previous step yields a positive outcome , Neoolife will contact you for further steps or to discuss our proposal. In case you

do not receive any feedback within two weeks, you have to consider that your profile does not matc h Neoolife’s expectations.

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