Business Analyst - PTC Windchill (Medical Devices / MedTech)

Job Description: Business Analyst - PTC Windchill (Medical Devices / MedTech)
Location: Milwaukee WI (Hybrid)
Duration: 12+ Months
Experience: 10 Years

Role Summary

We are seeking a Business Analyst who can demonstrate Windchill OOTB capabilities end-to-end, create realistic derno 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.

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 propression, and release vie 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:

OOTB-first approach and where organizations typically configure vs customize

Common patterns for lifecycle governance, approvals, traceability, controlled documents, and change implementation

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, Ul 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.

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.

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