Senior Manufacturing Engineer

CL ee3e274c dbf7 4704 97cc 31141ae84cfc; Columbia (SC); On-site; USD 95,000 - 140,000; Full time

Job summary

CL is seeking a Senior Manufacturing Engineer to lead readiness, process improvement, and validation for durable and disposable medical devices in Columbia, SC. The role emphasizes data-driven decisions, regulatory compliance, and cross-functional collaboration to ensure scalable production and product quality.

The ideal candidate has a strong engineering background, 5+ years in manufacturing engineering, and experience with IQ/OQ/PQ validation in regulated environments.

Qualifications

• Bachelor's degree in a relevant engineering field and 5+ years in manufacturing engineering.
• Experience in medical devices or regulated environments (FDA/ISO).
• Ability to work on-site in Columbia, SC at least 4 days/week.
• Proficient in validation protocols such as IQ/OQ/PQ.

Responsibilities

• Lead manufacturing readiness, process improvement, and validation for products.
• Coordinate equipment installation, validation, and process verification.
• Analyze data to identify root causes and improve process performance.
• Develop validation protocols and change documentation per quality standards.
• Drive lean manufacturing and continuous improvement initiatives.
• Support NPI and production ramp, including capacity planning and tooling.
• Collaborate with engineering, quality, operations, and regulatory teams.
• Track milestones and communicate progress against timelines.

Skills

Technical judgment

Analytical problem-solving

Data analysis

Documentation

Regulatory understanding

NPI / design transfer

Cross-functional collaboration

CAD tools

Project management tools

Education

Bachelor's degree in Mechanical / Industrial / Biomedical Engineering

Tools

CAD software

Excel

Statistical analysis tools

Project management platforms

Job description

About the Role

We are seeking a Senior Manufacturing Engineer to lead manufacturing readiness, process improvement, and validation work for durable and disposable medical devices. This is an opportunity to make a meaningful impact on products that support patient care while helping shape efficient, scalable manufacturing operations. In this role, you will support product commercialization, improve production performance, and ensure manufacturing processes meet quality and regulatory requirements. You will join a team that values collaboration, steady execution, and continuous improvement, and the role is well suited for someone who takes ownership of technical decisions, works comfortably with complex data, and brings structure to fast-moving engineering challenges.

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
• Write and execute validation protocols, technical reports, and change documentation in compliance with regulatory and quality standards
• Drive lean manufacturing and continuous improvement initiatives to reduce waste, improve throughput, and strengthen product quality
• 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 reviews and provide actionable feedback to simplify production, reduce cost, and improve consistency
• Support process risk analysis, pilot builds, and launch readiness activities to help ensure smooth product transfers into manufacturing
• Track project milestones, communicate progress clearly, and support execution against timelines and operational priorities

Required Skills & Abilities

• Strong technical judgment and the ability to make sound decisions in complex manufacturing environments
• Comfort working independently on analytical, detail-intensive engineering problems
• Ability to troubleshoot production issues using data, testing, and structured problem-solving methods
• Strong documentation skills, including validation protocols, reports, and change control records
• Working knowledge of regulated manufacturing environments such as FDA, ISO, or similar quality systems
• Experience supporting new product introduction, design transfer, or manufacturing scale-up activities
• Experience using engineering and project tools such as CAD software, Excel or statistical analysis tools, and project management platforms
• 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 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, and measuring equipment
• May be required to lift items up to 50 pounds