Manufacturing Manager / Senior Manufacturing Engineer

Roles & Responsibilities

We are partnering with a emerging US-based medical equipment manufacturer focusing on innovations that reduce preventable harm and improve health outcomes for maternal and newborn health issues. As part of their expansion, they are looking to hire the following position for their Singapore team.

Manufacturing Manager / Senior Manufacturing Engineer

Position Overview :

The role is responsible for leading critical initiatives to develop, setup and qualify manufacturing processes, ensure compliance with regulatory standards, and drive innovation in our product development efforts. As a key member of the Technical team, he / she will also be involved in maintaining and enhancing the quality, efficiency and scalability of our manufacturing operations. This role is part of the Engineering team and reports to the VP of Engineering and Manufacturing. This is a pioneering position and the first one in our small team that will be fully dedicated to manufacturing.

Key Responsibilities :

• Lead the collaboration with external vendors and contract manufacturers to define and develop manufacturing equipment and processes for Class I and II products. This includes process characterization, equipment buy-off, validation, and scale-up activities in compliance with ISO 13485 and FDA regulations (21 CFR Part 820).
• Evaluate and enhance existing manufacturing processes to improve efficiency, yield, and cost-effectiveness while maintaining product quality and regulatory compliance for existing products.
• Lead initiatives to implement new technologies, processes and materials to advance manufacturing capabilities and reduce costs.
• Lead root cause analysis and implement corrective / preventive actions (CAPA) to address manufacturing issues or manufacturing related product complaints to prevent recurrence.
• Collaborate with contract manufacturers to develop and review manufacturing procedures, work instructions and other manufacturing documents.
• Close collaboration with cross functional team from Quality Assurance, Supply Chain, Regulatory Affairs and contract manufacturers to ensure product and process integrity throughout the product life cycle.
• Drive continuous improvement initiatives using Lean, Six Sigma, or other methodologies to optimize processes and eliminate waste.
• Collaborate closely with Engineering team, contract manufacturers and external vendors to ensure seamless transfer of new products into manufacturing.
• Support new product introduction through Design for Manufacturability (DFM), process development and production readiness.
• Ensure contract manufacturers and external vendors implement best practices and compliance with international EHS (Environment, Health & Safety) requirements.

Requirements :

Skills Requirements :

EA Personnel Registration No : R1106329

EA License No : 12C6254

Tell employers what skills you have

FDA

FMEA

Manufacturing Processes

ISO

Root Cause Analysis

Process Validation

Manufacturing Operations

Characterization

Injection Molding

Medical Devices

Molding

Assembly

Manufacturing

Six Sigma

EHS