MANUFACTURING ENGINEER

Role Purpose

The Manufacturing Engineer is responsible for supporting and improving manufacturing processes across molding and/or assembly operations. This includes process validation, troubleshooting, documentation, and continuous improvement initiatives. The role ensures that production meets quality, cost, and delivery targets while complying with regulatory and safety standards.

You will report directly to the Manufacturing Engineering Lead and work in close collaboration with cross-functional production and operations teams. You will be responsible for driving operational excellence and leading transformation initiatives.

Key Responsibilities

Process Engineering & Support

• Provide technical support to molding and/or assembly/ automation operations, including troubleshooting equipment and process issues.

• Apply scientific molding principles and advanced troubleshooting techniques to optimize process stability and reduce variation.

• Conduct root cause analysis and implement corrective/preventive actions.

• Support mold/tooling trials and validations (IQ, OQ, PQ).

• Maintain and improve process documentation, work instructions, control plans and FMEA.

Continuous Improvement & Operational Impact

• Identify and implement process improvements to enhance yield, reduce waste, improve cycle time, and support achievement of production KPIs (OEE, scrap rate, cost efficiency).

• Participate in lean manufacturing, 6S, Kaizen, and automation initiatives to enhance efficiency and scalability.

• Collaborate with Business Excellence to drive data-driven improvements and transformation projects.

• Manage Engineering Change Notifications (ECN) according to our quality management system, including evaluation, impact assessment, validation and implementation to ensure smooth transition and production stability.

Compliance & Documentation

• Ensure compliance with ISO 13485, FDA QSR, and other regulatory requirements.

• Support internal and external audits with relevant documentation and technical input.

• Maintain accurate and updated documentation (BOM, specifications, routing, revision control) to reflect latest product changes.

• Maintain accurate records of process changes, validations, and engineering activities.

Customer Communication

• Communicate with customers on product changes, technical clarifications, and improvement actions to ensure accurate and timely responses.

• Review customer change requests, assess manufacturability and risk impact, and drive internal actions to support lifecycle improvements.

Cross-Functional Collaboration & Mentorship

• Work with QA/RA to ensure product quality and regulatory compliance.

• Partner with Maintenance to ensure equipment reliability and uptime.

• Collaborate with NPI and Engineering teams to support new product realization.

• Provide technical coaching and training to operators and technicians to build process knowledge and capability.

Reporting & Analysis

• Monitor process performance metrics and report deviations.

• Prepare and present process performance reports, highlighting trends, root causes, and improvement actions.

• Provide technical input for CAPA, MRB, and change control processes.