IT PLM and Engineering Solution Architect

Intuitive; Sunnyvale (CA); On-site; USD 140,000 - 210,000; Full time

Job summary

Intuitive is seeking a highly analytical Solution Architect for PLM & Engineering Applications to design, configure, and integrate the digital backbone of our product development engine.

The role owns the technical design of the enterprise PLM platform and its ecosystem of CAD/CAE/EDA integrations, with emphasis on data integrity and regulatory compliance in the Medical Device industry.

Qualifications

• Deep hands-on expertise with industry-leading PLM platforms.
• Intimate understanding of compliance and quality guardrails in Medical Device industry.
• Ability to translate engineering and regulatory requirements into robust software solutions.
• Experience with CAD/CAE/EDA tooling integration.

Responsibilities

• Author and maintain high-level technical designs and architectures for the enterprise PLM platform and connected engineering application suites.
• Lead the design and technical definition of PLM object models, lifecycles, workflows, access controls, and security classifications.
• Define the technical setup, installation standards, and data management interfaces for core engineering tools—including CAD, CAE/Simulation, and EDA tools.
• Design and implement robust, secure, real-time integrations connecting CAD-to-PLM and PLM-to-downstream enterprise systems (ERP, MES, QMS).
• Architect automated logic for transitioning eBOM to mBOM and DMR within ERP.
• Ensure system designs support medical device compliance mandates (FDA 21 CFR Part 11, ISO 13485) and audit trails.
• Mentor internal developers, guide system integrators, and evaluate upcoming releases and cloud paths.

Job description

Job Description

Position Overview

We are seeking a highly analytical and technically proficient Solution Architect for PLM & Engineering Applications to design, configure, and integrate the digital backbone of our product development engine.

In this role, you will be the primary technical architect responsible for translating complex engineering and regulatory requirements into robust, scalable software solutions. You will own the technical design of part of our enterprise Product Lifecycle Management (PLM) platform and its deeply embedded ecosystem of Computer-Aided Design (CAD), simulation (CAE), and integrations with upstream and downstream systems. The ideal candidate brings deep hands-on expertise with industry-leading PLM platforms and an intimate understanding of the unique compliance and quality guardrails required by the Medical Device Industry.

Your mission will be to eliminate technical friction for our engineering teams, ensure absolute data integrity across the digital thread, and architect a future-proof technology stack.

Key Responsibilities

Solution Architecture & System Design

• End-to-End Architecture: Author and maintain high-level technical designs, data models, and system architecture blueprints for the enterprise PLM platform and connected engineering application suites.
• Core PLM Configuration: Lead the design and technical definition of PLM object models, lifecycles, workflows, access controls, and security classifications.
• Engineering App Ecosystem: Define the technical setup, installation standards, and data management interfaces for core engineering tools—including CAD (e.g., Creo, SolidWorks, NX), CAE/Simulation (e.g., Ansys), and electronic design automation (EDA) tools.

Digital Thread Integration

• Enterprise Connectivity: Design and implement robust, secure, and real-time integrations connecting CAD-to-PLM and PLM-to-downstream enterprise systems (such as SAP/Oracle ERP, MES, and QMS) using modern integration methodologies (REST APIs, middleware, and web services).
• BOM Transformation: Architect the automated logic and data mapping for transitioning an Engineering Bill of Materials (eBOM) within PLM into a Manufacturing Bill of Materials (mBOM) and Device Master Record (DMR) within ERP.

Medical Device Compliance & Quality

• Regulated Workflow Design: Ensure all system designs natively support medical device compliance mandates, including FDA 21 CFR Part 11 and ISO 13485 (electronic signatures, strict audit trails, and data history tracking).
• Validation Collaboration: Partner closely with Quality and Computer Software Validation (CSV) teams to author technical specifications, risk assessments, and execution protocols (IQ/OQ/PQ) for system rollouts.

Technical Leadership & Implementation

• SME Guidance: Act as the ultimate Subject Matter Expert (SME) for engineering systems, mentoring internal developers, guiding system integrators, and resolving complex tier-3 technical bottlenecks.
• Roadmap Evaluation: Conduct continuous proof-of-concepts (PoCs) and technical evaluations of upcoming software releases, cloud migration pathways, and vendor patches to determine business impact.