Beschreibung

In this role, you will be at the forefront of developing innovative drug delivery systems, collaborating with diverse teams to ensure product safety and quality. Your day-to-day responsibilities will involve leading assembly processes, maintaining critical documentation, and driving solutions to enhance device performance.

Anforderungen

• •Degree in mechanical engineering or equivalent
• •5 years of experience in medical device development
• •Proficient spoken communication and excellent technical writing skills in English
• •Proven experience in assembly of plastic and metal components / sub-assemblies
• •Proven experience in design for manufacturing and design for assembly
• •Good knowledge in key regulations and standards (e.g. ISO 13485, ISO 23908, ISO 11608, ISO 10993, MDR, Design Controls)
• •Ability to interact with cross functional team in matrix organization
• •Travel to visit suppliers and CMOs

Aufgaben

• •Develop platforms for drug delivery systems
• •Collaborate with cross-functional teams to ensure product safety and reliability
• •Lead assembly teams for device parts and design equipment
• •Support processes from prototyping to commercial scale
• •Create and maintain Design History File (DHF) documents
• •Contribute to medical device development phases: ideation, prototyping, piloting, and manufacturing transfer
• •Ensure components meet quality standards for clinical trials and production
• •Collaborate with external partners, including prototypers and toolmakers
• •Identify root causes of issues and implement effective solutions