Senior Manufacturing Engineer - Medical Devices (On-Site)

Rhythmlink; Columbia (SC); On-site; USD 90,000 - 115,000; Full time

Job summary

Rhythmlink is seeking a Senior Manufacturing Engineer to lead readiness, improvements, and validation for medical devices. The role focuses on manufacturing scalability, quality, and regulatory compliance in a fast-moving environment.

You will drive product commercialization, improve production performance, and ensure processes meet FDA/ISO standards, while collaborating across engineering, quality, and operations teams.

Qualifications

• Requires a Bachelor's degree in a engineering discipline and 5+ years in manufacturing engineering.
• Experience with regulated manufacturing environments (FDA/ISO) and equipment validation IQ/OQ/PQ.
• Proven ability to lead NPI, design transfer, and manufacturing scale-up efforts.

Responsibilities

• Lead manufacturing engineering support for product launches and sustained production.
• Coordinate equipment installation, validation, and process verification.
• Analyze data to identify root causes and drive process improvements.
• Prepare validation protocols, technical reports, and change controls per quality standards.
• Drive Lean initiatives to reduce waste and improve throughput.
• Lead new product introduction activities from development through ramp.
• Collaborate with cross-functional teams on manufacturability and equipment planning.
• Conduct design-for-manufacturability reviews and provide actionable feedback.

Skills

Technical judgment

Analytical thinking

Data problem-solving

Documentation

Regulated environments

NPI / design transfer

CAD software

Cross-functional collaboration

Project management tools

Education

Bachelor's degree in Mechanical Engineering

Industrial Engineering

Biomedical Engineering

Tools

CAD software

Excel

Statistical analysis tools

Project management platforms

Job description

Rhythmlink is seeking a Senior Manufacturing Engineer to lead readiness, improvements, and validation for medical devices. The role focuses on manufacturing scalability, quality, and regulatory compliance in a fast-moving environment.

You will drive product commercialization, improve production performance, and ensure processes meet FDA/ISO standards, while collaborating across engineering, quality, and operations teams.