Job Title: Manufacturing Engineer Location: Onsite – Madison, WI Pay Rate: 48-54/hr. (W2) Job Summary

The Manufacturing Engineer is responsible for providing technical guidance and support for manufacturing methods, tooling, test systems, process documentation, and equipment to ensure efficient and compliant medical device manufacturing. This role promotes continuous improvement and ensures all operations conform to internal quality systems, ISO 13485, and regulatory standards. This position involves cross-functional collaboration and direct support to production, engineering, quality, and materials teams. The ideal candidate is an experienced problem-solver with strong technical skills, project management experience, and the ability to work independently in a fast-paced, regulated environment.

Key Responsibilities

Own and support manufacturing processes, test systems, tooling, and documentation to ensure compliance with quality and regulatory requirements. Provide process expertise and act as SME for production and process controls. Train and guide production associates on new and existing processes, equipment, and documentation. Troubleshoot production issues and collaborate across teams to implement cost-effective solutions. Develop and revise SOPs, Work Instructions, Process Flow Diagrams, Device History Records, and validation documentation. Participate in continuous improvement efforts to enhance yield, manufacturability, and efficiency. Serve on the Material Review Board (MRB); investigate nonconforming devices and components. Define and execute verification and validation (V&V) plans. Provide inputs on manufacturing strategies, capital planning, and facility maintenance. Assist with cost estimation for new products. Support equipment troubleshooting and participate in supplier development initiatives. Use statistical analysis and lean tools for root cause investigations and process optimization. Perform other duties as needed to support operational and business objectives.

Required Qualifications

Education: Associate’s degree in Electrical or Mechanical Engineering (equivalent combination of experience, education, and training accepted). Experience: Experience as a Manufacturing Engineer or Engineering Technician preferred. Prior experience in a medical device manufacturing or technical support role is highly desirable. Technical Skills: Working knowledge of ISO 13485, FDA 21 CFR regulations. Proficient in MS Office (Word, Excel, etc.); SAP and LabView experience a plus. Familiarity with Lean Six Sigma (Green Belt certification preferred).

Key Competencies

Leadership and ability to train/guide manufacturing teams. Strong organizational and time management skills. Effective communicator with strong interpersonal and cross-functional collaboration skills. Skilled in root cause analysis, process improvements, and project execution. Ability to manage multiple projects and priorities in a regulated environment.

Organizational Relationship & Scope

Reports to the Manufacturing Engineering/Facilities Manager. Works cross-functionally with Sustaining Engineering, Global Device Engineering, QA, Regulatory, and Technical Operations. Responsible for new product introduction, process optimization, and production support.

Working Conditions

Mix of hands-on manufacturing line support, computer-based work, and cross-functional meetings. May require extended hours, weekends, or holidays with manager approval.