PURPOSE OF JOB

We are seeking a skilled Medical Device Manufacturing Engineer to join our manufacturing team. This role is responsible for designing and optimizing manufacturing processes, creating comprehensive documentation, and sustaining production lines for medical devices in a regulated environment. The ideal candidate will have experience in fixture design, process optimization, and working within FDA/ISO quality standards.

MAJOR DUTIES AND RESPONSIBILITIES

Manufacturing Line Sustaining

• Provide ongoing technical support for production lines to ensure consistent output and quality
• Investigate and resolve manufacturing deviations, non-conformances, and customer complaints
• Support production scale-up activities and technology transfers
• Train production personnel on new processes and equipment
• Coordinate with cross-functional teams including Quality, Regulatory, and R&D

Fixture Design & Tooling

• Design, develop, and validate manufacturing fixtures, jigs, and tooling for medical device assembly and testing processes
• Create detailed engineering drawings and specifications using CAD software
• Collaborate with machining vendors and internal teams to ensure fixtures meet design requirements and delivery timelines
• Perform fixture qualification studies and document results per regulatory requirements

Manufacturing Process Optimization

• Analyze existing manufacturing processes to identify opportunities for improvement in efficiency, quality, and cost reduction
• Implement lean manufacturing principles and continuous improvement methodologies
• Conduct time studies, capability analyses, and statistical process control initiatives
• Design and execute process validation protocols (IQ/OQ/PQ) for new and modified processes
• Troubleshoot production issues and implement corrective and preventive actions

Manufacturing Documentation

• Develop and maintain manufacturing procedures, work instructions, and process specifications
• Create and update manufacturing drawings, assembly procedures, and quality control documentation
• Ensure all documentation complies with FDA regulations, ISO 13485, and company quality standards
• Maintain accurate revision control and document management systems

EDUCATION REQUIREMENTS

• BS or MS in Engineering or related discipline or equivalent experience in the medical device industry

EXPERIENCE REQUIREMENTS

• 3-5 years of experience working on FDA Class II or Class III medical device manufacturing or regulated manufacturing environment
• Proficiency in CAD software (SolidWorks, AutoCAD, or similar)
• Strong understanding of manufacturing processes including machining, injection molding, assembly, and testing
• Knowledge of FDA regulations (21 CFR Part 820) and ISO 13485 quality management systems
• Experience with statistical analysis tools and process validation methodologies
• Experience working on Injection molding or inserting molding (Desired)
• Experience working on electro-mechanical medical devices
• Strong problem-solving skills and attention to detail
• Excellent written and verbal communication skills
• Experience in manufacturing and controlling sterile product

REQUIRED SKILLS/ ABILITIES

• Knowledge of and experience in pilot/production line set-up and validation in Controlled Environments
• Experience working under quality system designed to meet governmental regulations such as FDA QSR, ISO 13485, the MDR, and knowledge of relevant standards
• Ability to detail project plans effectively
• Familiar with developing Master Validation Plans & executing operational and performance validations
• Familiar of GMP, GDP procedures and requirements
• Familiar with Design Control procedures and requirements
• Excellent verbal and written communication skills are required

• Experience working to environmental health and safety regulations
• Project management experience preferred