Senior Manufacturing Engineer

Senior Manufacturing Engineer

Rhythmlink International is a Columbia, South Carolina-based medical device manufacturer specializing in neurodiagnostic connectivity products used in EEG, EMG, and intraoperative neuromonitoring (IONM). The company supports manufacturing across Columbia, Costa Rica, and Shenzhen, China, giving its engineering team the opportunity to work across a truly global operation.

Rhythmlink has built a highly regarded workplace culture, including 15 years of recognition as a Best Place to Work in South Carolina. This Senior Manufacturing Engineer will join a collaborative engineering environment with meaningful exposure to new products, continuous improvement, manufacturing scalability, and global cross-functional work.

The Senior Manufacturing Engineer performs engineering duties for product commercialization of durable and disposable medical devices. This position is responsible for the initial manufacturing of product launch and duties include coordinating equipment installations, process changes, quality/cost improvements, and sustained engineering for both the Columbia and Shenzhen Manufacturing operations. Responsibilities also include managing change requests, analyzing data from equipment and process verification testing to provide recommendations for product safety and efficacy, writing and performing written protocols for equipment and process validations that meet final design(s), the user needs, and is compliant with FDA, MET/UL and/or other regulatory bodies.

Knowledge, skills, and abilities include:

• Knowledge of manufacturing and engineering medical devices or consumer products.
• Knowledge of process control under FDA 21 CFR 820.30 or a similarly regulated industry-standard (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 the use of MS Excel or statistical software for analysis.
• Proficient in the use of 3-D SOLIDWORKS CAD (and/or using a similar package such as Inventor, Pro-E) for machine or tooling design
• Ability to effectively use Project Management (PM) software such as 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 a clear and concise manner, using MS Office Suite, MS-VISO, Outlook, and other software.
• Ability to clearly communicate status and prepare reports of the assigned project team and report progress to Management

Key responsibilities include:

Lean Manufacturing & Continuous Improvement

• Implement lean engineering principles and practices 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 the acquisition of capital equipment.
• Participate in greenfield startup projects, leveraging your expertise to set up efficient and scalable manufacturing operations.
• Collaborate with cross-departmental teams to design, develop, and implement new manufacturing processes and technologies.

Champion design for manufacturability best practices across the product development lifecycle to reduce cost, improve quality, and shorten time-to-market:

• Apply DFM/DFA (Design for Assembly) principles during all phases of product design, providing actionable feedback to engineering teams to simplify geometry, reduce part count, and eliminate unnecessary complexity.
• Conduct formal DFM reviews and generate documented recommendations covering material selection, tolerances, surface finishes, joining methods, and assembly sequences.
• Evaluate component and sub-assembly designs for compatibility with existing manufacturing capabilities; flag designs that require new capital investment or specialized processes.
• Partner with suppliers and contract manufacturers to assess DFM compliance of outsourced components, ensuring off-site production aligns with quality and cost targets.
• Utilize tools such as Solid Works, tolerance stack-up analysis, and Minitab to model and validate design changes before implementation.
• Quantify and communicate the manufacturing cost impact of design decisions, driving value engineering efforts that reduce COGS without compromising product performance or regulatory compliance.
• Maintain a DFM knowledge base and standard design guidelines to support consistent, repeatable product development across all engineering teams.
• Drive change control activities resulting from DFM feedback, ensuring full traceability within the quality management system.
• Collaborate with cross functional departments to incorporate DFM insights into incoming inspection criteria,…