Client is seeking an experienced Manufacturing Engineer with a strong background in medical device production to join their dynamic manufacturing team. The ideal candidate will have 3+ years of experience in medical device manufacturing, with expertise in both electro-mechanical devices and single-use disposable products such as catheters. This role requires a versatile professional who can manage multiple complex projects while ensuring compliance with stringent medical device industry standards and regulations.

Company Profile

Client is a smaller medical device company that specializes in the development and manufacturing of Class III active implantable devices.

Primary Responsibilities:

• Process Development & Optimization: Design, develop, and optimize manufacturing processes for medical devices, including electro-mechanical assemblies and single-use disposable products such as catheters, ensuring efficient production while maintaining quality standards.

• Technical Documentation: Write, review, and maintain comprehensive manufacturing procedures, work instructions, Standard Operating Procedures (SOPs), and process specifications in compliance with FDA regulations and ISO 13485 standards.

• Fixture & Tooling Design: Design, develop, and implement manufacturing fixtures, tooling, and equipment for production of medical devices, ensuring proper functionality and compliance with design controls.

• Problem Solving & Continuous Improvement: Lead root cause analysis investigations, implement corrective and preventive actions (CAPA), and drive continuous improvement initiatives to enhance product quality, reduce waste, and improve manufacturing efficiency.

• ERP System Management: Utilize Epicor ERP system to manage Bills of Materials (BOMs), routing operations, work orders, inventory management, and production planning activities.

• Cross-Functional Collaboration: Work closely with Quality Assurance, Regulatory Affairs, R&D, and Production teams to ensure seamless product launches and manufacturing transfers.

• Regulatory Compliance: Ensure all manufacturing processes comply with FDA 21 CFR Part 820 (Quality System Regulation), ISO 13485, and other applicable medical device regulations.

• Production Support: Provide technical support to production floor, troubleshoot manufacturing issues, and implement solutions to maintain production schedules and quality targets.

• Design Controls: Participate in design control activities including Design History Files (DHF), risk analysis, and validation/verification protocols.

• Training & Mentoring: Train production personnel on new procedures and processes, and mentor junior engineering staff.

Qualifications:

Education: Bachelor’s degree in manufacturing engineering, Mechanical Engineering, Biomedical Engineering, or related technical field

Experience: Minimum 3 years of experience in medical device manufacturing engineering • Proven experience with electro-mechanical device assembly and testing • Experience with single-use disposable medical devices (catheters, guidewires, or similar products) Demonstrated experience with Epicor ERP system or similar enterprise resource planning software • Experience with FDA-regulated manufacturing environments

Technical Skills: Proficiency in CAD software (SolidWorks, AutoCAD, or similar) Knowledge of statistical process control (SPC) and lean manufacturing principles • Understanding of medical device design controls and validation processes • Experience with process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)

Regulatory Knowledge: Thorough understanding of FDA 21 CFR Part 820 Quality System Regulation • Knowledge of ISO 13485 Medical Device Quality Management System • Familiarity with ISO 14971 Risk Management for Medical Devices • Understanding of biocompatibility requirements (ISO 10993) for medical devices

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