Medical-Device PLM & Engineering 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

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.