Manufacturing Engineer

Job Title: Manufacturing Engineer

Location: Madison, WI

Employment Type: [Contract]

Reports To: Manufacturing Engineering / Facilities Manager





Job Summary:



We are seeking a detail-oriented and proactive Manufacturing Engineer to support and improve manufacturing processes, tooling, equipment, test systems, and documentation within a regulated medical device manufacturing environment. The Manufacturing Engineer will ensure compliance with quality systems and regulatory requirements, including ISO 13485 and FDA regulations, while driving continuous improvement initiatives across production operations.





Key Responsibilities:

• Provide technical guidance and support for manufacturing methods, tooling, test systems, and process documentation.
• Ensure compliance with company quality systems, FDA 21 CFR, ISO 13485, and customer requirements.
• Own and manage process validation (IQ/OQ/PQ), change controls, and documentation updates such as SOPs, Work Instructions, Device History Records, and Process Flow Diagrams.
• Collaborate with cross-functional teams including Sustaining Engineering, Quality, Regulatory, Supply Chain, and Production.
• Lead or support root cause analysis (RCA) and corrective and preventive actions (CAPA) related to manufacturing issues.
• Train and mentor Production Associates on revised processes, equipment operation, and quality requirements.
• Act as a key member of the Material Review Board (MRB) to evaluate non-conforming materials and feed insights into the continuous improvement cycle.
• Drive lean manufacturing initiatives, process optimization, and yield improvement efforts.
• Support cost estimation activities for new product introductions and process transfers.
• Provide engineering support during internal and external audits and inspections.

Qualifications:



Education & Experience:

• Associate's degree in Electrical or Mechanical Engineering (Bachelor's preferred); equivalent experience may be considered.
• 2+ years of hands-on experience as a Manufacturing Engineer or Engineering Technician in a regulated manufacturing environment; medical device experience preferred.
• Familiarity with SAP, LabVIEW, and manufacturing documentation systems is a plus.
• Experience with Lean Six Sigma tools; Green Belt certification is desirable.

Skills & Competencies:

• Strong technical knowledge of process controls, equipment validation, and production support.
• Excellent communication, leadership, and cross-functional collaboration skills.
• Proven ability to manage multiple projects, prioritize tasks, and meet deadlines in a dynamic environment.
• Working knowledge of manufacturing compliance standards (FDA QSR, ISO 13485).
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

Working Conditions:

• This role will be performed in both office and manufacturing floor settings.
• Must be able to support off-shift duties, extended hours, or weekend work when necessary.
• Occasional travel may be required for training, audits, or supplier visits.