Senior Expert Engineering – Medical Device Development

Your Responsibilities: Your responsibilities include, but are not limited to: Work on platform device development and participate to project activities in cross‑functional teams to deliver easy‑to‑use, safe and robust products. Contribute to the complete development process of medical devices: ideation, brainstorming, prototyping, piloting, manufacturing and complaint handling. Create and review IP. Work with CAD, 3D, drawings, tolerance analysis. Size and specify plastic and metallic components. Work with third‑party suppliers, including prototyper, tool makers, CMOs. Manage testing and characterization for acceptance, compliance, performance etc., and implement improvements. Perform root cause analysis and develop robust solutions to prevent re‑occurrence. Ensure components are delivered and controlled to the required quality for clinical trials and commercial production. Author key design history file documents: design input requirements, component specifications and design verification documents. Role Requirements: Degree in mechanical engineering or equivalent. Preferably 10 years of experience in medical device development. Proficient oral communication and excellent technical writing skills in English is a must. Experience in designing plastic and metal components; tolerance analysis; metrology; lab testing. Experience in material qualification. Good knowledge in design for manufacturing and assembly. Good knowledge of key regulations and standards. Track record in Design History File documentation. Ability to interact with cross‑functional team in matrix organization. Minimum 80% on site work – 4 days/week.