Project Manager R&D Medical Devices
$28,000–$40,000 year
On-siteBovezzo, Lombardy, Italy
Job Summary
Translate market insights and user needs into comprehensive technical specifications and product roadmaps. Lead the definition of patient-centric product requirements to enhance ergonomics, comfort, and clinical efficacy. Execute detailed techno-economic feasibility analyses to ensure product viability and strategic alignment. Contribute to the company's IP portfolio through patentable engineering solutions and successfully reduce production costs using strategic DTC methodologies. Manage supplier relations to realize prototypes with additive manufacturing technologies, analyze data, and develop technical documentation according to Medical Devices EU regulations for CE certification. Ensure compliance with safety standards and prepare quality control checklists. This role supports Air Liquide Medical Systems' R&D team in developing innovative respiratory medicine devices, including ventilators and gas emanation systems, within an international engineering environment.
Required Qualifications
- Master degree in mechanical, biomechanical, biomedical or material engineer
- Previous experience in R&D teams developing products
- Good understanding of safety standards and environmental and ergonomics impact of a design
- At least a basic knowledge on design of injection moulds for engineering polymers and elastomers
- Ability to report in front of management
- Good oral and written communication skills
- Must be able to read standards
- Must be able to perform tests
- Must be able to create test reports
- Must be able to ensure the respect of timing
- Must be able to define and schedule main tasks together with different stakeholders both internal and external
- Must be able to create a project development plan
- Must be able to translate market insights and user needs into comprehensive technical specifications and product roadmaps
- Must be able to lead the definition of patient-centric product requirements to enhance ergonomics, comfort, and clinical efficacy
- Must be able to execute detailed techno-economic feasibility analyses to ensure product viability and strategic alignment with organizational objectives
- Must be able to contribute to the company's IP portfolio through the generation of patentable engineering solutions
- Must be able to successfully reduce production costs by implementing strategic DTC methodologies without compromising on medical-grade quality
- Must be able to ensure compliance with the company's safety standards
- Must be able to manage the relation with suppliers to realize prototypes with the most recently additive manufacturing technologies
- Must be able to analyze prototypes, data and test them if needed
- Must be able to manage documentation of both new and revised 3D designs
- Must be able to write detailed reports
- Must be able to assess the quality control on components and prepare check lists
- Must be able to develop technical documentation according to Medical Devices EU regulations to grant CE certification
Desired Qualifications
- Prior professional background within the healthcare sector
- Candidates with previous experience on medical devices conformity
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