Project Manager (Medical Devices - Steriles)
My client is a leading medium-structured medical device company in Italy, specialized in the design and production of Sterile Disposable Medical Devices. With over 50 years of history, the company sells its products (all of them ISO-certified and FDA-audited) both in the European and overseas markets.
In their R&D department, they are currently looking for a experienced Project Manager, responsible to drive development projects for the entire product life cycle. He/she will lead the new products design and the process development, as well as the design changes and the engineering support.
- Responsible and accountable for leading the project team to drive projects from the feasibility phase to the post-launch, including the whole or part of the product lifecycle
- Collaborates with other divisions (Marketing, QA/RA, Operations, Supply Chain, Finance) to ensure all aspects of the project requirements are managed and delivered on time and budget
- Directly manages or supervises all the design and development activities through the verification of product design inputs, validation of the intended use, shelf life, biocompatibility, food contact, packaging and transportation validation.
- Writes and reviews R&D verification and validation plans, protocols and reports related to product design. Oversees all other activities performed by other functions during development.
- Supervises the 'transfer to manufacturing' phase: gives support to definition, qualification or validation of new processes to be used for the product manufacturing cycle
- Keeps the product Device History File (DHF).
- MUST HAVE: minimum 3 years demonstrable experience in leading complex projects in R&D
- Master's Degree in Engineering, or similar relevant discipline
- Good understanding of Medical Device Product Development Processes and requirements and experience with Stage Gate methodologies.
- Definition and execution of reliable project timelines through the use of Microsoft Project.
- Project cost budgeting and forecasting.
- Experience in medical device design and/or manufacturing, or relevant similar products.
- Broad understanding of medical device development processes compliant with US FDA 21-CRF-820 and/or ISO 13485.
- Experience with risk management, including but not limited to Design Failure Mode Effects Analysis (DFMEA), Process Failure Mode Effects Analysis (PFMEA), fault tree analysis, or other risk management tools.
- Ability to read technical drawings and to use 2D and 3D CAD
- Working understanding of statistics, including sample size selection, Gage R&R, data distribution analysis, capability calculations, Design of Experiments (DOE), and Analysis of Variance (ANOVA).
- Ability to effectively communicate with and report to Top Management.
- Team leadership, communication and soft skills applied to a multicultural work environment.
- Excellent spoken and written English
Good to have:
- Lean and/or Six Sigma belt certification
- Ability to perform or at least understand Finite Element Analysis (FEA) on structural and fluid-dynamics application.
- Knowledge on plastic materials manufacturing technologies (injection molding, tube extrusion).
- Familiar with cleanroom production, high volume manufacturing environment of disposable devices.
- Familiar with standards/regulations ISO 10993, ISO 11607, EN 1615, EN 1618, ISO 80369, ISO 80369, ISO DIS 20695, ASTM D4169, ASTM F1980, EU Reg. 10/2011, REACH, MDR
To know more about the role, send an email to S.Bongiovanni@nonstop-recruitment.com and attach your CV (Word format).
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