Senior Manufacturing Engineer - Medical Devices & NPI

Talencio; Columbia (SC); On-site; USD 95,000 - 120,000; Full time

Job summary

Rhythmlink International, a Columbia, SC-based medical device manufacturer, seeks a Senior Manufacturing Engineer to drive product commercialization, lean improvements, and scalable processes across Columbia and Shenzhen operations.

You will own NPI from design transfer to production ramp, validate processes (IQ/OQ/PQ) to FDA 21 CFR Part 820 and ISO 13485, and collaborate with R&D, Regulatory, and Quality teams.

Qualifications

• Bachelor's degree in Mechanical/Industrial/Industrial Engineering or related field.
• Lean Six Sigma certification or equivalent experience.
• Knowledge of medical device manufacturing and regulatory requirements.

Responsibilities

• Lead lean engineering initiatives to optimize production workflows.
• Drive continuous improvement to enhance quality, reduce waste and increase throughput.
• Provide support for high-volume manufacturing operations and NPI ramp.
• Write and validate protocols for new/updated production equipment.

Skills

Lean manufacturing

Process optimization

NPI coordination

SolidWorks

FDA 21 CFR 820 knowledge

Data analysis (Excel/Minitab)

Project management

Regulatory compliance

Education

Bachelor's degree in Mechanical/Industrial Engineering

Lean Six Sigma certification

Tools

SolidWorks

MS Project

Minitab

MS Office

Job description

Rhythmlink International, a Columbia, SC-based medical device manufacturer, seeks a Senior Manufacturing Engineer to drive product commercialization, lean improvements, and scalable processes across Columbia and Shenzhen operations.

You will own NPI from design transfer to production ramp, validate processes (IQ/OQ/PQ) to FDA 21 CFR Part 820 and ISO 13485, and collaborate with R&D, Regulatory, and Quality teams.