Production Engineering / Quality Engineering

Role & responsibilities

• Design and develop, electronic/mechanical components for medical devices.
• Design, prototype, and test electronic or mechanical components and systems for medical devices.
• Develop and maintain product specifications, CAD models, and engineering drawings.
• Perform compliance testing and ensure adherence to medical device regulations (FDA, ISO 13485, etc.).
• Collaborate with cross-functional teams for product development and continuous improvement.
• Troubleshoot and resolve issues related to product functionality and manufacturing processes.
• Ensure quality control throughout the production process.
• Assist in preparing technical documentation and reports for product approvals.
• Participate in risk management activities and ensure device safety.
• Supervise the entire product lifecycle management from concept through production.

Preferred candidate profile

• Minimum 2-4 years of hands-on experience in product development, design, and manufacturing within the medical device or related industries (electronics or mechanical design).
• Experience with medical device regulations (ISO 13485, FDA 21 CFR Part 820) is highly desirable.