Senior Design Engineer – Medical Device Development

vor 1 Tag

Basel, Schweiz SimplyVision Vollzeit

For our customer located in Basel/Switzerland we are currently looking for a: Senior Design Engineer – Medical Device Development (m/f/d)

  • Minimum 80% on site work – 4 days/week

  • Location: Basel

Tasks & Responsibilities

  • Work on platform development and participate in project activities in cross-functional teams for easy-to-use, safe, and robust products.

  • Participate in the complete development process of medical devices (ideation, brainstorming, prototyping, piloting, and transfer to manufacturing).

  • Create and review IP.

  • Create, manage, and maintain CAD, 3D models, and drawings.

  • Create, manage, and maintain tolerance analysis.

  • Size and specify plastic and metallic components.

  • Work with third-party suppliers, including prototypers, tool makers, and CMOs.

  • Write key design history file documents: design input requirements, component specifications, and design verification documents. Ensure device design development is delivered to a high quality.

  • Manage testing and characterization for acceptance, compliance, performance, etc., and suggest 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.

Must Haves

  • Degree in mechanical engineering or equivalent.

  • Preferably 10 years of experience in medical device development.

  • Proficient spoken communication and excellent technical writing skills in English.

  • 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 in key regulations and standards (e.g., ISO 23098, ISO 11608, ISO 10993, MDR, Design Controls).

  • Design History File documentation.

  • Ability to interact with cross-functional teams in a matrix organization.

Did we catch your interest?

The SimplyVision-Team is looking forward to receiving your application (Word file is highly appreciated).

Kindly be informed that our customer is located in Switzerland. Therefore, only applications from candidates within the EU or candidates holding Swiss work permission are required.

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