Digital Manufacturing Solution Lead

We are seeking a Digital Manufacturing Solution Lead with strong shop-floor manufacturing experience to drive discovery, alignment, and solution definition for advanced digital and predictive analytics initiatives in regulated Med Tech and Pharma manufacturing environments.

This is not a traditional IT Business Analyst role
.

The role is deeply embedded in CNC machining, inspection, and production operations
, and requires hands‑on understanding of how machines, operators, maintenance teams, and quality systems interact on the shop floor.

You will work onsite at a Med Tech manufacturing facility
, collaborating closely with manufacturing engineers, automation engineers, CNC and CMM technicians, quality teams, supervisors, and operations leaders
.

You will act as the single onsite bridge between plant‑floor reality and an offshore AI, machine learning, and software engineering team
, ensuring that digital solutions are grounded in real operational needs and regulatory expectations.

• Lead structured, hands‑on discovery across CNC machining, CMM inspection, MES, QMS, and related manufacturing systems
• Understand and document machining workflows, routing, batch execution, traceability, inspection flows, tooling usage, downtime drivers, and rework loops
• Identify gaps in digitalization, automation, and data capture across legacy and modern equipment
• Translate operational pain points into high‑impact digital and predictive analytics opportunities aligned with Industry 4.0 principles

• Analyze data generated by CNC machines, CMMs, and production systems (for example: MTConnect, OPC Unified Architecture (OPC-UA), machine logs, CSV, XML, historian extracts)
• Understand machine cycles, cutting programs, tool changes, alarms, process deviations, and production states
• Assess data availability, quality, gaps, and integration constraints across different machine generations
• Prepare machine connectivity maps, data flow diagrams, and readiness assessments for predictive analytics

• Convert shop‑floor understanding into clear, structured documentation including:
• Business Requirements Documents (BRDs)
• Functional Specification Documents (FSDs)
• User stories and acceptance criteria
• Data dictionaries and process workflows
• Standard Operating Procedures (SOPs)
• Define current‑state (As‑Is) and future‑state (To‑Be) processes aligned to manufacturing realities
• Support solution architecture discussions by validating feasibility with plant teams
• Work closely with Quality and IT/OT teams to align with ISO 13485, MDR, FDA 21 CFR 820, GxP
  , and validation expectations

• Understand constraints of deploying digital and machine learning solutions in regulated manufacturing environments
• Document cybersecurity, operational technology (OT) demilitarized zones (DMZs), firewall rules, access controls, and data flow requirements
• Coordinate with IT and OT teams to enable secure, compliant data connectivity
• Provide informed input on on‑premises, cloud, and hybrid deployment models, with production uptime as the top priority

• Act as the primary onsite point of contact between the client manufacturing teams and offshore engineering teams
• Facilitate machine access, data extraction activities, operator interviews, and validation workshops
• Support user acceptance testing, dashboard validation, machine learning model review cycles, and change readiness
• Ensure continuous communication, expectation alignment, and stakeholder buy‑in across operations, maintenance, quality, and leadership
• Contribute to program governance, milestone tracking, and delivery coordination

• 5+ years of experience in Med Tech, Pharma, or other regulated manufacturing environments
• Hands‑on exposure to CNC machining, CMM inspection, automation cells, or precision manufacturing operations
• Strong understanding of manufacturing systems such as MES, QMS, SCADA, or historians
• Proven experience producing structured requirements, workflows, and…