Senior Medical Device Manufacturing Engineer (Global NPI)

Rhythmlink International, LLC; South Carolina; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Rhythmlink International, LLC, a Columbia, SC-based medical device manufacturer, seeks a Senior Manufacturing Engineer to lead the initial manufacturing for product launches and coordinate equipment installations, process changes, and sustaining engineering for Columbia and Shenzhen operations.

You will drive Lean manufacturing, DFMA, and New Product Integration efforts, write validation protocols, ensure FDA and ISO compliance, and collaborate with R&D, Quality, Regulatory, and Supply Chain to

Qualifications

• Knowledge of manufacturing and engineering medical devices or consumer products.
• Knowledge of process control under FDA 21 CFR 820.30 or QS9000/ISO/MIL/FDA.
• Effective speaking and visual presentation skills for management presentations, training, and technical presentations.
• Strong ability to troubleshoot manufacturing issues.
• Strong analytical skills with MS Excel or statistical software for analysis.
• Proficient in SolidWorks CAD (and/or using Inventor/Pro-E) for machine or tooling design.
• Ability to use MS Project to document strategies, milestones, and timelines, identifying critical path components for success.
• Ability to clearly document all plans, daily communications, and work performed in MS Office Suite, MS-VISO, Outlook, and other software.

Responsibilities

• Implement lean engineering principles to optimize production workflows.
• Drive continuous improvement initiatives to enhance quality, reduce waste, and increase throughput.
• Provide critical support to high-volume manufacturing operations, ensuring seamless production runs.
• Write protocols and reports to validate new or updated production equipment.
• Support the development of business cases for capital equipment acquisitions.
• Participate in greenfield startup projects to set up efficient, scalable manufacturing operations.
• Collaborate with cross-functional teams to design, develop, and implement new manufacturing processes and technologies.

Skills

Manufacturing knowledge

Regulatory knowledge

Presentation skills

Troubleshooting

Data analysis

CAD skills

PM software

Documentation

Communication

Education

Bachelor's degree in Mechanical/Industrial/Biomedical Engineering

Lean Six Sigma certification

Tools

SolidWorks

Inventor

Pro-E

Minitab

MS Project

MS Excel

MS Office Suite

Job description

Rhythmlink International, LLC, a Columbia, SC-based medical device manufacturer, seeks a Senior Manufacturing Engineer to lead the initial manufacturing for product launches and coordinate equipment installations, process changes, and sustaining engineering for Columbia and Shenzhen operations.

You will drive Lean manufacturing, DFMA, and New Product Integration efforts, write validation protocols, ensure FDA and ISO compliance, and collaborate with R&D, Quality, Regulatory, and Supply Chain to