*This is an onsite role located in Columbia, SC. Relocation assistance is provided.*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. Position 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 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
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.
- Design for Manufacturability (DFM)
- 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 SolidWorks, 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, in-process controls, and acceptance test procedures.
New Product Integration:
Lead and support the introduction of new products from development into full-scale manufacturing, ensuring a smooth and controlled transition that maintains quality and schedule commitments:
Serve as the primary manufacturing engineering liaison during new product development (NPD) phases, engaging early in the design process to influence manufacturability.
Develop and execute New Product Introduction (NPI) plans, including process development, tooling, fixtures, work instructions, and capacity planning.
Collaborate with R&D, Quality, Regulatory, and Supply Chain teams to translate product designs into robust, scalable manufacturing processes.
Lead process Failure Mode and Effects Analysis (pFMEA) for new products to identify and mitigate manufacturing risks prior to launch.
Establish and validate manufacturing processes, equipment, and controls (IQ/OQ/PQ) in compliance with FDA 21 CFR Part 820 and ISO 13485 quality system requirements.
Drive design reviews with a manufacturing focus, providing formal input on cost, cycle time, yield, and process capability.
Create and maintain Bills of Materials (BOM), routers, and process documentation within the QMS and ERP systems.
Manage the pilot build and ramp-up phases, coordinating cross-functional resources to resolve production issues and meet launch targets.
Track and report NPI milestones, risks, and key performance indicators (KPIs) to Engineering and Operations leadership.
Education, Training, and Experience:
Bachelor's degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, or a related field.
Minimum of 5+ years of experience in a medical device, or related, manufacturing/design role.
Lean Six Sigma certification or working knowledge of Lean Six Sigma methodologies.
Proven experience in lean engineering methodologies, with a track record of successful process optimization.
Demonstrated expertise in supporting high-volume manufacturing operations.
Experience leading or supporting New Product Introduction (NPI) programs from design transfer through production ramp.
Working knowledge of DFM/DFA principles and ability to provide formal, documented design feedback.
Familiarity with FDA 21 CFR Part 820, ISO 13485, and equipment validation protocols (IQ/OQ/PQ).Proficiency in SolidWorks, Minitab, and related manufacturing software and tools.
Excellent communication and interpersonal skills, enabling seamless collaboration with cross-functional teams.
Why Rhythmlink:
This is a distinctive manufacturing engineering opportunity for someone who enjoys solving problems beyond a single production floor. The role supports projects across global manufacturing sites and offers the chance to contribute to new product commercialization, process improvement, capacity expansion, and manufacturing initiatives in a collaborative, recognized workplace. This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Additional responsibilities and duties will be required depending on a variety of factors.
