NPI Engineer with a Mechanical Background

We are looking for a talented and experienced NPI (New Product Introduction) Engineer with a strong mechanical engineering background to join our development team and lead the transition from design to mass production.

Responsibilities:

• Lead NPI processes from the design phase through to serial production.
• Work closely with R&D, Quality, and Procurement teams in a small, dynamic company environment.
• Prepare manufacturing documentation, technical specifications, and procedures.
• Provide support for production transfer, including troubleshooting and resolving engineering issues on the production floor.
• Plan and execute experiments, validations, and process improvements.
• Perform failure analysis and lead CAPA (Corrective and Preventive Actions) processes.

Requirements:

• B.Sc. in Mechanical Engineering – mandatory.
• Experience working with medical devices – mandatory.
• Proficiency in SolidWorks – mandatory.
• 3+ years of experience in an NPI or similar role – strong advantage.
• Experience working in a multidisciplinary environment.
• Ability to work independently and as part of a team, excellent task ownership and interpersonal communication skills.
• Fluency in English – both written and verbal.

Advantages:

• Experience working with PLM and ERP systems.
• Familiarity with quality and regulatory standards (e.g., FDA, ISO)