Manufacturing Engineer

Job Title:

Manufacturing Engineer

Job Description

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.

+ Assist with 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.

+ Support process improvement initiatives and continuous improvement projects, including change order requests and implementation of process changes.

+ Collaborate with suppliers and internal stakeholders to support supplier qualification, address sourcing issues, and manage long lead time components.

+ Contribute to end-to-end product lifecycle activities from design through validation and manufacturing, ensuring design for manufacturability and smooth transitions.

Essential Skills

+ 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 Solid Works for fixture and tooling design.

+ Proficiency with Microsoft Office, including Excel and Word.

+ Experience in process improvement and implementation of change order requests.

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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.

Additional

Skills & Qualifications

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Experience with ERP systems; any ERP is acceptable.

+ Exposure to quality management systems (QMS), such as Qualio or similar platforms.

+ Experience…