Manufacturing Process Engineer

Manufacturing Process Engineer

Job Summary

• Responsible for driving manufacturing process improvement activities to support business objectives related to quality, productivity, cost, and compliance.
• Mechanical Engineering professional with 4+ years of experience in manufacturing processes and operations.
• Experience in the medical device or regulated manufacturing industry preferred.

Roles & Responsibilities

• Support attainment of key business metrics through engineering support for manufacturing and value stream processes.
• Drive elimination of safety and quality risks through robust engineering solutions.
• Support machinery maintenance systems, equipment, fixtures, and manufacturing tooling.
• Lead cost reduction initiatives focused on scrap reduction, rework elimination, and consumable optimization.
• Develop and modify tools, fixtures, gauges, and special equipment in collaboration with internal teams and external vendors.
• Develop stable and capable manufacturing processes using structured process development methodologies.
• Perform process capability, scrap, and cost analyses to improve operational efficiency and reduce waste.
• Execute process validation activities, including IQ, OQ, and PQ, in accordance with Quality Management System (QMS) requirements.
• Conduct Process Risk Assessments and PFMEA activities to identify and mitigate potential failure modes.
• Prepare and maintain manufacturing specifications, work instructions, and technical documentation.
• Support validation of new materials, consumables, and process changes.
• Ensure timely closure of Audit Actions, NCRs, CAPAs, and other quality-related actions.
• Collaborate with cross-functional teams to support continuous improvement and operational excellence initiatives.
• Utilize standard business applications, including Microsoft Word, Excel, PowerPoint, Outlook, and project planning tools.
• Support laboratory controls, material evaluations, supplier validations, and material specification updates where applicable.

Required Qualifications

• Bachelor''s Degree in Mechanical Engineering or related discipline.
• Minimum 4 years of experience in Manufacturing Engineering, Process Engineering, or Operations.
• Experience in medical device manufacturing or other regulated industries.
• Knowledge of process validation, risk management, PFMEA, CAPA, NCR, and Quality Management Systems.
• Strong analytical, problem-solving, and communication skills.
• Ability to work effectively with cross-functional teams and external suppliers.