Manufacturing Engineer

Manufacturing Engineer Position Overview

Our client is seeking an experienced Manufacturing Engineer to design, implement, validate, and continuously improve manufacturing processes for medical device products. The Manufacturing Engineer will work collaboratively with Engineering, Quality Assurance, Research and Development, and Production teams to ensure manufacturing processes are safe, efficient, repeatable, compliant, and capable of consistently producing high-quality products.

This role will have responsibility for developing and maintaining manufacturing documentation, designing production processes and equipment, supporting process validation, troubleshooting manufacturing issues, and driving continuous improvement across safety, quality, productivity, lead time, and cost.

The ideal candidate has strong medical device manufacturing experience, a solid understanding of regulated manufacturing environments, and the ability to work independently while collaborating effectively across functions.

• Design, develop, implement, and maintain manufacturing processes for medical device products.
• Develop Process Failure Mode and Effects Analyses (PFMEAs), Process Flow Diagrams, manufacturing cell and line layouts, process routers, Standard Operating Procedures (SOPs), and Work Instructions.
• Design manufacturing processes with a focus on safety, quality, productivity, cost, and repeatability.
• Specify and implement manufacturing equipment, tooling, fixtures, and production systems.
• Develop and optimize automated, semi-automated, and manual assembly and test processes.
• Ensure manufacturing processes are appropriately documented and controlled throughout the product lifecycle.

• Develop, execute, and document equipment qualification and process validation activities.
• Perform and support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Develop validation protocols, reports, and supporting documentation in accordance with applicable quality requirements.
• Ensure manufacturing equipment and tooling are properly documented and maintained under appropriate calibration and preventive maintenance controls.
• Identify opportunities to automate or improve production equipment and tooling.

• Participate in FMEA activities to identify potential process failures, risks, and opportunities for improvement.
• Partner with Quality Assurance to ensure manufacturing processes comply with applicable quality system requirements.
• Collaborate with Quality Assurance and Research and Development to maintain an effective internal Quality System.
• Support compliance with FDA GMP, Quality System Regulation (QSR), ISO 13485
  , and other applicable regulatory and quality requirements.
• Identify root causes of manufacturing process nonconformities and develop appropriate corrective and preventive actions.
• Utilize NCMR and CAPA processes to investigate issues, implement corrective actions, and prevent recurrence.

• Support pilot production and product introduction activities.
• Provide technical support to Production throughout the manufacturing process.
• Ensure production operators are appropriately trained on manufacturing processes, equipment, and work instructions.
• Monitor production activities to ensure schedules are met and required documentation is complete and accurate.
• Work directly with production personnel to identify process issues, inefficiencies, and improvement opportunities.
• Troubleshoot manufacturing issues and implement effective technical solutions.
• Provide engineering support during production ramp-up and ongoing manufacturing operations.

• Continuously improve manufacturing processes to enhance safety, quality, lead time, productivity, and cost
  .
• Analyze manufacturing data and process performance to identify opportunities for improvement.
• Implement lean and process improvement methodologies where appropriate.
• Evaluate manufacturing processes for opportunities to reduce waste, improve throughput, and increase process reliability.
• Partner with cross-functional teams to implement sustainable process improvements.

• Work closely with Design Engineers to ensure products are designed for manufacturability, reliability, quality, and cost effectiveness.
• Collaborate with Research and Development during product development, pilot production, and transfer activities.
• Partner with Quality Assurance to resolve process issues and maintain compliance.
• Work with Production teams to ensure manufacturing processes are practical, efficient, and consistently executed.
• Communicate technical information clearly to engineering, quality, production, and other stakeholders.

This role operates in a regulated medical device manufacturing environment and requires frequent collaboration with Engineering, Quality, R&D, and Production teams.

The successful…