Summary
We are seeking a highly skilled and experienced Senior Manufacturing Process Engineer to join our team. The ideal candidate will have a strong background in the Electronics Manufacturing Services (EMS) industry, with a focus on medical device manufacturing. This role requires a hands-on individual with a deep understanding of manufacturing processes, quality protocols, and regulatory compliance.
Responsibilities
- Process Ownership: Serve as the subject matter expert for backend assembly processes, ensuring efficiency, quality, and reliability.
- Process Validation: Lead and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for new and existing equipment and processes.
- Risk Management: Conduct and manage Process Failure Mode and Effects Analysis (PFMEA) to proactively identify and mitigate manufacturing risks.
- Customer Interaction: Act as the primary technical point of contact for internal medical customers, understanding their needs and ensuring that manufacturing processes meet their strict requirements.
- Regulatory Compliance: Ensure all manufacturing activities and documentation comply with FDA Part 21 protocols and other relevant regulatory standards.
- Continuous Improvement: Drive process improvements to increase yield, reduce cycle time, and lower costs.
- Equipment Management: Provide technical support for manufacturing equipment, with a strong preference for experience with Ultrasonic welding machines.
- Collaboration: Work closely with customer, Quality, and Production teams to ensure a smooth transition from design to manufacturing.
Qualifications
- Experience: A minimum of 5 years of experience as a Manufacturing Process Engineer in an Electronics Manufacturing Services (EMS) environment.
- Industry Knowledge: Proven experience working with and handling the requirements of international medical customers.
- Technical Skills: Hands-on experience with backend assembly processes.
- Validation Expertise: In-depth knowledge and practical experience with IQ, OQ, and PQ.
- Quality Tools: Well-versed in PFMEA.
- Regulatory Knowledge: Strong understanding of FDA Part 21 protocols.
- Specialized Experience: Experience with Ultrasonic welding machines is a significant advantage.
- Soft Skills: Excellent problem-solving, communication, and interpersonal skills. A proactive and detail-oriented approach is essential.
