Manufacturing Engineer
Location: Mequon, WI
Department: Engineering
Reports to: Manufacturing Engineering Manager
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
Summary
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.
ESSENTIAL DUTIES AND RESPONSIBILITIES
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.
Manufacturing Strategy & Process Ownership
- 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.
Advanced Design Interface & System Integration
- 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.
Customer & Program Leadership
- 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.
Operational Excellence & Continuous Improvement
- 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.
Validation, Compliance & Technical Governance
- 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.
Tools & Fixtures
- Apply CAD tools (SolidWorks) 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 continuous improvement within manufacturing operations.
KNOWLEDGE, SKILLS AND ABILITIES REQUIRED
- Associate’s degree in Electrical, Biomedical, Mechanical, Industrial, or Manufacturing Engineering Technology, or a minimum of two (2) years of relevant manufacturing engineering experience; equivalent experience will be considered.
- Experience working in electromechanical or system-level manufacturing environments, preferably within regulated industries.
- Ability to manage multiple concurrent assignments and adapt to changing priorities in fast-paced manufacturing environments.
- Proven experience developing and maintaining procedures, work instructions, rework documentation, and process or software validations, with proficiency in Microsoft products and the ability to read and interpret drawings, prints, and bills of material (BOMs).
- Strong analytical, organizational, and problem-solving skills with attention to detail and responsiveness.
- Excellent written and verbal communication skills, with the ability to collaborate effectively across engineering, manufacturing, quality, supply chain, operations, suppliers, and customers.
- Demonstrated commitment to continuous improvement, including proactive risk identification, issue escalation, and corrective action execution.
- Ability to handle confidential and controlled design data in accordance with documentation, configuration control, and quality system requirements.
- Willingness to support cross-functional engineering initiatives and additional projects as assigned.
- Willingness to travel domestically and internationally on an infrequent basis, as required.
PHYSICAL REQUIREMENTS AND WORKING CONDITIONS
The physical demands described here are representative of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The phrases “occasionally,” “regularly,” and “frequently” correspond to the following definitions: “Occasionally” means up to 1/3 of working time, “regularly” means between 1/3 and 2/3 of working time, and “frequently” means 2/3 and more working time.
Manufacturing Engineers typically split their time between office and production floor environments (approximately 70% office / 30% manufacturing floor). Occasional domestic or international travel may be required to support suppliers, customers, or other GMI sites.
This role requires mobility to work in both office and factory settings, including standing, walking, bending, and use of standard office equipment. Occasional lifting of up to 50 pounds may be required. Work areas may include moderate noise or dust. Vision, hearing, and speech must be sufficient for reading documentation and communicating in person or by phone.
This position is factory based, in Mequon, WI
Why Join Us?
- Competitive compensation and benefits
- Monthly company lunches or happy hours
- A collaborative, supportive team culture
- Be part of a company that’s investing in technology, talent, and transformation
If you're ready to grow your career and want to be part of a company that’s embracing the future, we’d love to hear from you.
Ready to shape the future? Apply now!
Apply now - email us at work4us@gmisolutions.com.
Revised 12/18/2025
