Senior Manufacturing Engineer

We are seeking a Senior Manufacturing Engineer to support product commercialization, manufacturing readiness, and sustained engineering for durable and disposable medical devices. This role plays a key part in launching new products, improving production performance, and ensuring manufacturing processes meet quality and regulatory requirements across multiple manufacturing operations. It is a strong fit for someone who brings technical depth to complex manufacturing challenges, works comfortably with data and documentation, and applies structure to process development, validation, and continuous improvement efforts.

• Lead manufacturing engineering support for product launches, process changes, and sustained production across multiple manufacturing operations
• Coordinate equipment installation, validation, and process verification activities to support safe, effective, and scalable production
• Analyze manufacturing and test data to identify root causes, improve process performance, and recommend practical solutions for product safety and efficacy
• Write and execute validation protocols, technical reports, and change documentation in compliance with FDA, quality, and other applicable regulatory standards
• Drive lean manufacturing and continuous improvement initiatives to reduce waste, improve throughput, and strengthen product quality
• Support high-volume manufacturing operations by resolving production issues and improving workflow efficiency
• Lead and support new product introduction activities from development through production ramp, including process development, tooling, work instructions, and capacity planning
• Partner with cross-functional teams to improve manufacturability, support capital equipment planning, and implement new production technologies
• Conduct design-for-manufacturability and design-for-assembly reviews, providing actionable feedback to simplify production, reduce cost, and improve consistency
• Support process risk analysis, pilot builds, launch readiness, and greenfield startup activities to help ensure smooth product transfers into manufacturing
• Use project management tools to document strategies, milestones, timelines, and critical path dependencies, and communicate progress clearly to management

• Strong technical judgment and the ability to make sound decisions in complex manufacturing environments
• Ability to troubleshoot production issues using data, testing, and structured problem-solving methods
• Strong analytical capability using Excel, statistical tools, or similar software to evaluate manufacturing and verification data
• Strong documentation skills, including validation protocols, reports, change control records, and daily technical communications
• Working knowledge of regulated manufacturing environments such as FDA 21 CFR 820.30, ISO, or similar quality systems
• Experience supporting new product introduction, design transfer, manufacturing scale-up, or sustained engineering activities
• Proficiency with engineering and project tools such as 3D CAD software, Excel or statistical analysis tools, and project management platforms
• Ability to communicate project status clearly through reports, presentations, and cross-functional updates
• Ability to collaborate effectively across engineering, quality, operations, regulatory, and leadership teams while maintaining ownership of assigned work

• Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, or a related technical field
• 5+ years of experience in manufacturing engineering, preferably in medical devices, consumer products, or another regulated manufacturing environment
• Familiarity with equipment validation protocols such as IQ/OQ/PQ
• Ability to work on-site in Columbia, SC at least 4 days per week
• Ability to use standard office, laboratory, hand, and measuring equipment
• Must be able to sit for extended periods of time
• May be required to lift items up to 50 pounds