Manufacturing Engineer

About the role

This Manufacturing Engineer role supports and improves manufacturing operations for regulated medical device products, with a strong focus on process efficiency, product quality, and regulatory compliance. You will work cross-functionally with production, quality, and R&D teams to troubleshoot issues, implement process improvements, and support new product introduction from design through validation and transfer into production.

Responsibilities

• Provide day-to-day engineering support to production and product development teams to ensure stable, efficient, and compliant manufacturing operations.
• Develop, optimize, and improve manufacturing processes, tooling, and equipment to enhance product quality, increase throughput, and reduce costs.
• Troubleshoot and resolve production issues related to processes, equipment, and fixtures, ensuring minimal downtime and robust corrective actions.
• Lead and support process validation activities (IQ, OQ, PQ) for new and existing manufacturing processes and equipment.
• Investigate non-conformances and lead corrective and preventive actions (CAPA), including root cause analysis and implementation of sustainable solutions.
• Maintain, create, and update manufacturing documentation, including specifications, work instructions, and document change requests (DCRs) and change orders.
• Support new product introduction (NPI) and transfer activities from R&D into production, ensuring processes are validated, documented, and ready for scale-up.
• Partner closely with Quality to improve inspection methods, refine acceptance criteria, and ensure compliance with applicable regulations and standards.
• Create, implement, and monitor statistical process control (SPC) charts and other process metrics to drive consistency, reduce variability, and improve process capability.
• Aid in preventative maintenance planning and equipment support to improve equipment reliability and uptime.
• Support equipment validation and equipment maintenance activities to ensure manufacturing assets operate within validated states.
• Train production personnel on new or updated processes, equipment, fixtures, and documentation to ensure consistent execution on the manufacturing floor.
• Contribute to end-to-end product lifecycle activities from design through validation and manufacturing, ensuring design for manufacturability and smooth transitions.
• Collaborate with suppliers and internal stakeholders to support supplier qualification, address sourcing issues, and manage long lead time components.
• Contribute to continuous improvement initiatives and structured problem-solving.
• Support process improvement initiatives and continuous improvement projects, including change order requests and implementation of process changes.

Requirements

• Bachelor’s degree in Engineering or a related technical field.
• 5+ years of experience in a regulated manufacturing environment, with medical device experience highly preferred.
• At least 2+ years of experience working as a Manufacturing Engineer.
• Working knowledge of FDA Quality System Regulation (QSR).
• Working knowledge of ISO 13485:2016 or similar medical device quality standards.
• Working knowledge of EU Medical Device Regulation (EU MDR 2017/745).
• Hands-on experience with process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Experience conducting non-conformance investigations and leading CAPA activities.
• Strong understanding of statistical process control (SPC) and process improvement methodologies.
• Proficiency with SolidWorks for fixture and tooling design.
• Proficiency with Microsoft Office, including Excel and Word.
• Experience in process improvement and implementation of change order requests.
• Experience with manufacturing processes, equipment validation, and equipment reliability in a regulated environment.
• Experience working in or supporting a quality management system within a highly regulated industry.

Essential Skills

• Experience with ERP systems; any ERP is acceptable.
• Exposure to quality management systems (QMS), such as Qualio or similar platforms.
• Experience supporting supplier qualification or resolving sourcing issues.
• Exposure to the full product lifecycle from design through validation and manufacturing.
• Experience working with international suppliers and managing long lead times.
• Background in medical device manufacturing or other highly regulated industries.
• Experience with continuous improvement initiatives and structured problem-solving.
• Experience with document change orders and change control processes.
• Experience with preventive maintenance planning and equipment maintenance coordination.
• Ability to build strong cross-functional relationships with production, quality, R&D, and supply chain teams.