Manufacturing Engineering Engineer II
Job Summary
The Engineer II supports Singapore operations by managing new product introductions, process engineering, and sustaining engineering. This role focuses on developing, improving, and validating manufacturing processes to ensure high-quality production standards. Additionally, the position serves as a senior team member responsible for mentoring junior engineers and leading cross-functional improvement initiatives.
Responsibilities
- Manage new product introductions and process engineering
- Develop, improve, and validate manufacturing processes
- Lead cross-functional continuous improvement teams
- Mentor and provide technical guidance to junior engineers
- Ensure compliance with GMP, ISO13485, and FDA regulations
Required Skills
- 5-8 years high-volume production experience
- Medical device manufacturing & catheter production knowledge
- Proficiency in DOE, SPC, and CAD software
- Expertise in FMEA, IQ/OQ, TMV, and validation protocols
- Strong communication and leadership capabilities
Job Details
Essential Duties & Responsibilities:
- Evaluate and improve manufacturing processes through research, product design, and collaboration with vendors and operators.
- Design and develop processes for new products, changes, and enhancements, including tooling and fixtures.
- Troubleshoot processes, refine throughput, and design fixtures and assembly techniques.
- Improve efficiency by analyzing workflow, space, and equipment layout.
- Lead process qualifications and validations, including equipment and material specifications.
- Ensure product and process quality through testing and establishing standards.
- Provide decision-making information by calculating costs and reviewing schedules.
- Prepare reports by analyzing and summarizing trends.
- Maintain equipment by coordinating maintenance and repairs.
- Ensure Health & Safety, including accident investigation and corrective action.
- Investigate and evaluate new process technologies.
- Mentor and guide junior engineers by providing technical support and facilitating knowledge transfer.
- Lead cross-functional teams to drive continuous improvement initiatives.
- Comply with EHS, ISO13485, GMP, FDA regulations, and GDP requirements.
Education/Experience and Qualifications:
- Bachelor in Engineering or similar technical field with 5 to 8 years’ experience in a high-volume production environment. Medical Device Manufacturing experience with knowledge of catheter production techniques is preferred.
- Strong interpersonal skills with the ability to communicate effectively at all levels.
- Proficient in DOE and statistical techniques (SPC).
- Knowledgeable in defining process capabilities and control charting.
- Strong and meticulous in documentation and record management; ability to manage Engineering Change Order.
- Experience in writing protocols for validations and qualifications including FMEA, MVP, IQ/OQ & TMV.
- Proficiency with CAD software is required.
- Knowledge of GMPs, ISO 9001, ISO13485 and the Medical Device Directives.
- Self-motivated and driver of change and innovation; willing to work in a fast-paced environment.