MECHANICAL ENGINEER WITH ENGLISH
Descripción de la oferta de empleo
The company believes in shared success and diverse ways of thinking, here you’ll learn, grow, and advance in an innovative culture.
As a Mechanical Engineer you will be contributing to the design, development, and test of mechanical systems.
These mechanical systems are part of a complex CNS neuromodulation implant and its peripheral equipment.
This active medical device will be released in EU, requiring CE mark according to the MDR, and in the USA, requiring FDA approval.
Also you will investigate, create concepts, design, develop and test mechanical components, assemblies, and systems.
Main Responsibilities Lead the design, assembly, prototyping, and testing of mechanical components for an implantable CNS neuromodulation system, collaborating with various teams Collaborate with clinicians, users, and team members to refine mechanical component design requirements and guidelines Use design methodologies for reliability, manufacturing, and testing, including analysis and modeling Generate detailed documentation for device design compliant with ISO standards Coordinate with external partners for outsourced mechanical component design, assembly, and testing Develop test plans and methodologies to ensure device safety and compliance Design, build, and execute experimental setups for testing purposes Identify potential subcontractors for mechanical development and prototype construction Apply DFR/DFM/DFT principles in design processes Collaborate with cross-functional teams in product development procedures and reviews Core Skills/experience BS or MS in Mechanical Engineering +5 years of work experience in a relevant industrial setting (regulated environment, MedTech is a strong plus) with proven experience executing a full development cycle Experience in developing multidisciplinary medical devices is a plus Demonstrated skills in the areas required to perform this job.
Mechanical CAD design, selection of medical-grade materials and components, safety and performance testing, requirements based Design, etc.
Ability to manage projects mandated to external sub-contractors and manufacturing Strong hands-on skills, and experience with workshop tools Desirable machining knowledge Fast learner, self-motivated and pro-active individual able to work in the fast-moving environment of a dynamic start-up company Preferred to have solid experience in neuroscience with a strong interest in gaining a further understanding of this field Preferred to have solid experience in (MDR) Medical Device Regulation, ISO Quality environments, ISO Risk Analysis and IEC
Detalles de la oferta
- Sin especificar
- Sin especificar
- 08/05/2024
- 06/08/2024
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