Senior Manufacturing Engineer: Med Device NPI & Validation

Rhythmlink International, LLC; Columbia (SC); On-site; USD 85,000 - 125,000; Full time

Job summary

Rhythmlink International, LLC is seeking a Senior Manufacturing Engineer to lead manufacturing readiness, process improvement, and validation for durable and disposable medical devices in Columbia, SC. This role drives product commercialization, improves production performance, and ensures processes meet quality and regulatory requirements.

You will collaborate with cross‑functional teams to support new product introductions, transfer processes, and scalable manufacturing solutions while

Qualifications

• Degree in a related mechanical/industrial/biomedical field.
• Experience in medical devices or regulated manufacturing environment.
• Familiarity with IQ/OQ/PQ and validation protocols.
• On-site work in Columbia, SC at least four days a week.

Responsibilities

• Lead manufacturing readiness and validation activities across multiple operations.
• Coordinate equipment installation and process verification.
• Analyze data to identify root causes and improve performance.
• Develop and execute validation protocols and change documentation.
• Drive Lean and continuous improvement to reduce waste and improve throughput.
• Lead new product introduction from development through ramp, including process development and capacity planning.
• Collaborate with cross-functional teams to improve manufacturability and capital planning.
• Conduct design-for-manufacturability reviews and provide actionable feedback.
• Support process risk analysis, pilot builds, and product transfers.
• Track milestones and communicate progress to leadership.

Skills

Analytical thinking

Independent problem-solving

Data-driven decision making

Documentation and validation

Regulatory quality systems (FDA/ISO)

NPI / design transfer experience

Cross-functional collaboration

CAD software proficiency

Education

Bachelor's degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering

Tools

CAD software

Excel

Statistical analysis tools

Project management software

Job description

Rhythmlink International, LLC is seeking a Senior Manufacturing Engineer to lead manufacturing readiness, process improvement, and validation for durable and disposable medical devices in Columbia, SC. This role drives product commercialization, improves production performance, and ensures processes meet quality and regulatory requirements.

You will collaborate with cross‑functional teams to support new product introductions, transfer processes, and scalable manufacturing solutions while