Project Manager - Medical Devices
Great Growth Opportunity
Il nostro cliente
La figura ricercata
The Project Manager (PM) is part of the R&D Department and is responsible to drive development projects for the entire product lifecycle. Responsibilities will include leadership and Project Management of new products/components design and new process development, design changes and engineering support.
Day in the life:
- 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 and drives projects leveraging the relevant input from Marketing, QA/RA, Operations, Supply Chain, Finance etc to ensure all aspects of the project requirements are considered, 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 (eg support to mold qualification, process validation, equipment IQ, OQ and PQ).
- The PM is the keeper of the product Device History File (DHF).
- Proactively collaborate with peers and functional managers to improve the organization processes.
Il candidato prescelto
- Minimum 3 years demonstrable experience in leading complex projects in R&D and/or engineering environment
- Advanced Degree - M.S. 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.
Cosa comprende l'offerta
Great Growth Opportunity