Senior Manufacturing Engineer

About the Role

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.

Core Responsibilities

• 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

Required Skills & Abilities

• 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

Other Requirements

• 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