Senior Manufacturing Engineer - Medical Devices (On-Site)

Rhythmlink International LLC

Columbia (SC)

On-site

USD 90,000 - 115,000

Full time

13 days ago

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Job summary

Rhythmlink International LLC in Columbia, SC, is seeking a Senior Manufacturing Engineer to lead readiness, process improvement, and validation for medical devices. You will drive production readiness, support commercialization, and ensure processes meet quality and regulatory standards.

The role emphasizes collaboration, lean initiatives, and ownership of technical decisions, with on-site work required four days per week and involvement in design-for-manufacturability reviews and transfers to

Qualifications

Bachelor’s degree in Mechanical, Industrial, or Biomedical Engineering.
5+ years in manufacturing engineering, ideally in medical devices.
Familiarity with IQ/OQ/PQ validation protocols.
On-site in Columbia, SC at least 4 days a week.
Experience in regulated manufacturing environments.

Responsibilities

Lead manufacturing engineering support for launches, changes, and steady production.
Coordinate equipment installation, validation and process verification.
Analyze data to identify root causes and drive improvements.
Write validation protocols and change documentation per standards.
Drive lean manufacturing and continuous improvement.
Lead NPI activities from development to ramp.
Collaborate with cross-functional teams on manufacturability.
Perform design-for-manufacturability reviews.
Support risk analysis, pilot builds, and transfers to production.
Track milestones and communicate progress to leadership.