| Job Description: |
Role Summary
We are seeking a Business Analyst who can demonstrate Windchill OOTB capabilities end-to-end, create realistic demo data, and use prior experience to recommend leading practices for MedTech implementations on Windchill. The BA will drive requirements discovery, fit-gap analysis, and backlog creation while clearly distinguishing OOTB vs configuration vs customization. This role requires strong functional knowledge of what Windchill can do and what it can be extended/configured to do—without needing to perform the actual system configuration.
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Required Windchill Capability Expertise
· Item, BOM & Structure Management – Engineering BOM (EBOM), Manufacturing BOM (MBOM), and Service BOM concepts, including structure governance, revisions, and traceability
· Product Configuration & Variability – options, variants, effectivity, and controlled configuration practices within Windchill
· Change & Release Management – change objects, workflows, impact analysis, approvals, and audit-ready release traceability
· Document Management – controlled documents, lifecycles, revisions, approvals, and DHF/DMR-style linkages to parts and changes
· Regulatory & Compliance Data (UDI) – UDI data governance, linkage to items/documents, and regulatory traceability expectations
· Access, Security & Supplier Collaboration – roles, access controls, segregation of duties, and controlled external/supplier collaboration
Key Responsibilities
1) Demo Leadership (OOTB) with Realistic Data
· Create and curate demo-ready sample data (parts, BOMs, documents, changes, roles) to represent Medical Device scenarios.
· Build and deliver structured demos in a Windchill OOTB (or near-OOTB) instance covering key user journeys:
o Part creation, metadata capture, lifecycle progression, and release via promotions
o BOM creation/maintenance, structure navigation, where-used, basic alternates/substitutes (where enabled)
o Document control: controlled documents, revisions, approvals, linkages to parts (DHF/DMR style scenarios as applicable)
o Change workflows (e.g., PR/CR/CN/ECO patterns as implemented), impact analysis, approvals, and release traceability
· Develop demo scripts, scenarios, and walkthrough narratives tailored for Quality/Regulatory/Engineering audiences.
2) Leading Practices Guidance (Windchill + MedTech)
· Provide recommendations based on Windchill leading practices, particularly for regulated MedTech implementations, including:
o OOTB-first approach and where organizations typically configure vs customize
o Common patterns for lifecycle governance, approvals, traceability, controlled documents, and change implementation
o Practical trade-offs: validation/audit impact, maintainability, and upgrade risk
· Advise stakeholders on “what good looks like” for Windchill-enabled processes in medical device product development.
3) Fit-Gap: OOTB vs Configure vs Customize
· Drive fit-gap workshops and explicitly document:
o Requirements satisfied by Windchill OOTB
o Requirements achievable through configuration (types, attributes/IBAs, lifecycles, workflows, templates, roles/teams, promotions, access model concepts)
o Requirements requiring customization (extensions, UI changes, automation, integrations), including rationale and implications
· Clearly articulate what can be configured vs customized and the level of effort/impact, without needing to implement the configuration personally.
4) Requirements Gathering & Backlog Development
· Lead discovery sessions to capture process, data, role, and approval requirements across Part/BOM/Document/Change.
· Convert requirements into a prioritized Agile backlog:
o Epics, features, user stories, acceptance criteria
o Traceability of requirements to backlog items and demo scenarios
· Collaborate with Solution Architects and technical teams to refine story clarity, dependencies, and scope boundaries.
5) Stakeholder Facilitation & Communication
· Facilitate workshops, playback sessions, and executive/SME walkthroughs.
· Produce clear process flows, fit-gap summaries, and demo findings suitable for technical and non-technical stakeholders.
· Maintain strong alignment across Quality/Regulatory, Engineering, Manufacturing, and IT.
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Required Qualifications
· 6+ years experience as a Business Analyst / Functional Analyst in PLM programs, including 3+ years with PTC Windchill.
· Proven ability to demo Windchill OOTB capabilities confidently to diverse stakeholder groups.
· Experience creating representative demo data and building demo scenarios that reflect real product development and change workflows.
· Strong capability to distinguish and explain:
o What Windchill supports OOTB
o What can typically be achieved via configuration
o What usually requires customization
· Medical Device / MedTech domain understanding, including regulated process expectations (controlled documents, approvals, audit trail, change traceability).
· Excellent communication, facilitation, and documentation skills.
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Example Deliverables
· Windchill OOTB demo scripts, scenarios, and sample data sets for MedTech workflows
· Fit-Gap matrix: OOTB vs Configure vs Customize (with rationale and impacts)
· As-is/to-be process flows and requirement traceability
· Prioritized product backlog with epics/features/user stories + acceptance criteria
· Playback deck summarizing recommendations and scope decisions |
