Manufacturing Systems Engineer - Medical

Job Purpose

VulcanForms is hiring a Manufacturing Systems Engineer for our Medical business unit. In this role, you will be responsible for building the manufacturing execution foundation required to launch, transfer, and scale products. This role owns the creation and coordination of the manufacturing system inputs, documentation, part number structure, Methods of Manufacture, travelers, routers, and data requirements needed to enable controlled, traceable, and repeatable production.

The role works cross-functionally with Engineering, Manufacturing Engineering, Quality, Supply Chain, Operations, IT, Planning, and other required stakeholders to ensure new products and changes are properly set up in Epicor, MES, and related data systems. This includes coordinating part number creation, BOM structure, routings, travelers, work instructions, inspection points, data collection requirements, and system workflows. This role is accountable for production readiness from a systems and documentation perspective. Routine production ownership, daily output, staffing, scheduling, and shop floor supervision remain owned by Operations / Production.

Key Responsibilities

• Develop and maintain manufacturing execution documentation (Methods of Manufacture, travelers, routers, work instructions) to support NPI, product changes, transfers, and scale-up.
• Translate engineering drawings, specs, BOMs, and customer requirements into clear, executable shop floor documentation with defined operations, inspection points, acceptance criteria, and traceability.
• Support pilot builds, first article/validation builds, and launch readiness reviews, identifying and closing documentation or routing gaps that pose execution, traceability, or quality risk.
• Coordinate part number, BOM, and routing creation/maintenance, ensuring master data is complete and accurate across Epicor, MES, and related systems prior to production release.
• Partner with Engineering, Quality, Supply Chain, Planning, and IT to define and enforce standards for master data quality, naming conventions, and revision control, and to support related change control activities.
• Define manufacturing system requirements and data capture needs (production, inspection, traceability, nonconformance, DHR/LHR) to ensure Epicor/MES configurations support intended processes.
• Support system testing, UAT, validation, training, and integration across Epicor, MES, QMS, and PLM, identifying gaps or workarounds to drive improvement.
• Serve as the NPI/Business Unit cross-functional interface, driving alignment on documentation and system readiness, supporting root cause investigations, and standardizing launch readiness processes.

Qualifications

• Bachelor's degree in Engineering, Manufacturing/Industrial Engineering, Operations, Information Systems, or related experience, plus 3+ years in NPI, manufacturing engineering, or manufacturing systems.
• Experience creating and maintaining manufacturing travelers, routers, work instructions, Methods of Manufacture, or equivalent shop floor execution documents.
• Experience working with ERP, MES, PLM, QMS, or related manufacturing data systems.
• Strong understanding of part numbers, BOMs, routings, item masters, inventory transactions, and traceability/inspection requirements.
• Ability to translate engineering and process requirements into executable manufacturing documentation and system requirements.
• Strong cross-functional communication skills across Engineering, Quality, Operations, Supply Chain, IT, Planning, and Production.
• Strong documentation discipline, attention to detail, and practical problem-solving skills.
• Experience in a regulated manufacturing environment (medical device, aerospace, defense, automotive, pharma) with familiarity in FDA QSR, ISO 13485, AS9100, or similar quality standards.

VulcanForms offers a competitive salary and equity package. Actual compensation is based on factors such as the candidate's skills, qualifications, and experience. In addition, VulcanForms provides comprehensive benefits including medical, dental, vision, and life insurance; generous paid time off; and a 401(k) plan with company match.

The annual base salary range for this position is $80,000 to $111,000.