Associate Director of Engineering (Medical Device)

Our client, a global B2B medical device manufacturer, is seeking a Senior Engineering Manager to lead the engineering function at its manufacturing site in Chonburi, Thailand – an established and growing site that plays a strategic role in the company’s global operations.

Chonburi is located about 45 minutes from Bangkok and is one of Thailand’s leading industrial zones, home to many global manufacturers and modern industrial parks.

This is a senior-level position with full responsibility for leading engineering activities, driving process improvements, and supporting tech transfers and new product introductions.
We’re looking for a leader with proven experience in medical device manufacturing, strong technical expertise and a hands-on approach – someone who combines strategic thinking with operational involvement and a deep understanding of production processes.

The size of the team is 20+ employees. The Associate Director reports directly to the global VP of Engineering and dotted line to the local Site Director.

Responsibilities

• Lead a team of 20+ engineers.
• Monitor and manage NPI and MP.
• Lead, plan and execute process improvement projects, such as automation, localization of raw materials, VAVE, product design improvement etc.
• Coordinate and prioritize the allocation of engineering resource
• Oversee Process Engineering (PE) activities related to equipment management and Maintenance, providing technical support to production to ensure production plan attainment.
• Provide information for RFQ to PMO department. Working directly with Commercial Team and customers on technical topics.
• Research and solve the technical problems of NPI, providing customers with plans on improved or enhanced products
• Provide technical engineering support to production and other departments, including investigation on engineering related activities in regards to quality investigations on NCRs, CAPAs and customers complaints.
• Compliance to companies’ standards and procedures, including FDA, ISO 13485 etc.
• Lead the onboarding of new capabilities
• Provide technical data and coordinate efforts to resolve customer complaints, support after-sales service, and address production-related technical issues
• Take responsibilities of ECN/ECO, risk analysis and validation processes of electronics and medical products at NPI and MP phases.
• Work with Technology team to make smooth transition from NPD to NPI, as well as smooth implementation of some of the company’s new technologies and/or equipment.
• Drive and lead all automation initiatives and their implementation.
• Lead engineering related activities of production transfers between the companies’ sites.

Requirements

• Engineering Degree (Bachelor or above).
• Extensive experience of hands-on Engineering in Medical Device Industry.
• Experienced in leading the Engineering function in a managerial capacity
• Medical Device background – a must (preferably Class II/III).
• Exposure to T1KAs (preferably J&J, MDT, ABT) and Semi Auto implementations.
• Ability to develop and upskill engineering teams to meet future technological and business demands.
• Demonstrated leadership in manufacturing environments, characterized by a hands-on approach, strong
• technical acumen and experience leading multicultural and remote teams.
• Demonstrates the ability to think strategically while also actively engaging in daily operations, supported by a strong understanding of production processes.
• Extensive experience of NPI and MP (Key competencies: Production Transfer, Production Process Optimisation, supporting new product launches).
• Team player, structured, problem solver and good communicator.
• Strong leadership, interpersonal, and influential skills, with the ability to drive change management
• Ability to work under pressure in a fast-paced and dynamic environment