Manufacturing Engineer

Reports to:

About our environment

• GMI Solutions IS a well-established contract manufacturer established in 1983
• Team and family-oriented philosophy throughout
• Plenty of on-site amenities and special events

Under the direction of the Manufacturing Engineering Manager, the Manufacturing Engineer is a technically focused, systems-oriented professional responsible for the development, ownership, and sustainment of manufacturing processes supporting computer-centric electromechanical assemblies and integrated system solutions for medical and non-medical OEM customers.

This role is technology-driven and digitally fluent, with a strong orientation toward computer-based platforms, hardware–software integration, and data-enabled manufacturing systems.

The Manufacturing Engineer provides technical leadership across the product lifecycle, from quote/prototype through full run-rate production and sustaining, ensuring manufacturability, scalability, quality, and compliance.

The position partners closely with operations, quality, and supply chain to implement modern, computer-focused manufacturing solutions, drive continuous improvement, and support reliable, efficient production environments.

This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities as management may deem necessary to meet the needs of the organization from time to time, as needed.

• Own manufacturing strategies for complex, computer-based electromechanical systems across multiple programs or customers.
• Lead the development and optimization of manufacturing processes for low- to mid-volume, high-mix system-level products, ensuring scalability, cost control, and long-term sustainability.
• Establish manufacturing standards, best practices, and technical direction across assigned product families or technologies.
• Provide technical input to capacity planning, capital investment, and long-term manufacturing roadmaps.

• Serve as the manufacturing engineering interface for customers, providing guidance on system architecture, manufacturability, and production readiness.
• Lead DFM and system-integration reviews for computer-centric designs, including embedded systems, industrial PCs, and control architectures.
• Drive early engagement during quoting and design phases to influence cost, risk, and manufacturability outcomes.
• Own and coordinate ECO/MCO activities, BOM configuration changes, and production transitions.
• Act as a trusted technical advisor to customers, supporting programs from initial engagement through production and sustaining.
• Lead manufacturing engineering activities for strategic or high-complexity programs, including customer-facing technical reviews and escalation management.
• Balance customer requirements with operational capabilities to deliver manufacturable, compliant, and cost-effective solutions.

• Define and lead continuous improvement initiatives across manufacturing operations using Lean, Six Sigma, and data-driven methodologies.
• Identify systemic issues and lead cross-functional corrective actions addressing quality, reliability, cost, and delivery.
• Leverage manufacturing and quality data to drive strategic improvements and inform leadership decision-making.
• Lead risk management activities (FMEA/PFMEA) for complex systems, new product introductions, and process changes.

• Translate system-level design and functional requirements into clearly written, well-visualized, and controlled manufacturing documentation to ensure accurate execution and compliance.
• Provide oversight of process and equipment validations (IQ/OQ/PQ) and ensure manufacturing readiness for both new product introductions and sustaining production.
• Ensure manufacturing strategies, processes, and documentation align with ISO 13485 and applicable regulatory requirements.
• Support and lead customer, internal, and third-party audits as a manufacturing engineering subject matter expert. Ensure consistent application of configuration control, traceability, and documentation standards across manufacturing and quality systems.
• Develop, document, and maintain validated rework processes, and support service teams as required.
• Provide training and technical guidance to production and service teams on validated processes, work instructions, and quality requirements to ensure consistent execution and regulatory compliance.

• Apply CAD tools (Solid Works) and digital manufacturing platforms to design, validate, and implement production and test fixtures that support scalable manufacturing operations.
• Design and support metalwork, brackets, enclosures and cable assemblies to enable manufacturable, repeatable, and production-ready solutions.
• Leverage ERP/MES platforms and data analytics to drive visibility, traceability, and…