Manufacturing Engineer- Medical Devices

We are seeking an experienced Manufacturing Engineer with a strong background in medical device production to join our 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.

Requirements

DUTIES AND 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
• Other duties and projects assigned

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

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan with Company Match
• Paid Time Off, Personal Days, AND Birthday Holiday!
• Lifetime Membership Subsidy and Wellness Resources
• Life Insurance (Basic, Voluntary & AD&D)
• Family Leave (Maternity, Paternity)
• Short-Term & Long-Term Disability
• Taco Thursdays!!!

Nextern is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.