Senior Medical Devices Manufacturing Engineer (Hybrid)

Rhythmlink International, LLC; United States; Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Relocation assistance

Hybrid work model

Job summary

Rhythmlink International, LLC in Columbia, SC seeks a Senior Manufacturing Engineer to lead the manufacturing development and launch of medical devices within FDA-regulated environments. You will coordinate equipment installations, process changes, and validations across Columbia and Shenzhen operations.

The role emphasizes lean engineering, continuous improvement, and New Product Introduction with a focus on quality, cost, and schedule.

Qualifications

• Bachelor's degree in mechanical/industrial/biomedical engineering or related field.
• 5+ years in medical device manufacturing or design role.
• Lean Six Sigma certification or working knowledge.
• Experience with NPI programs and FDA/ISO regulatory environments.

Responsibilities

• Lead lean engineering initiatives to optimize production workflows.
• Support New Product Introduction (NPI) from design transfer to production ramp.
• Collaborate with R&D, Quality, Regulatory, and Supply Chain teams.
• Validate processes and equipment (IQ/OQ/PQ) and write protocols.

Skills

Lean manufacturing

Process optimization

Problem solving

Data analysis

Education

Bachelor's degree in Mechanical/Industrial/Biomedical Eng

Tools

SolidWorks

Minitab

Job description

Rhythmlink International, LLC in Columbia, SC seeks a Senior Manufacturing Engineer to lead the manufacturing development and launch of medical devices within FDA-regulated environments. You will coordinate equipment installations, process changes, and validations across Columbia and Shenzhen operations.

The role emphasizes lean engineering, continuous improvement, and New Product Introduction with a focus on quality, cost, and schedule.