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The Senior Quality Engineer oversees quality processes in manufacturing combination medical devices, leads defect reduction efforts, develops quality plans, and ensures regulatory compliance.

Develop and deploy AI-enabled applications for global supply chain and sourcing workflows. Translate ambiguous business needs into technical specifications, applications, data pipelines, ontology objects, validation logic, and production-ready solutions. Collaborate with business stakeholders, product owners, data teams, SMEs, and external engineers; validate applications, support user acceptance testing, troubleshoot data and system issues, document technical decisions, and sustain deployed solutions in a regulated environment.

Develop and deploy AI-enabled applications for global supply chain and sourcing workflows. Translate ambiguous business needs into production-ready applications, pipelines, ontology objects, validation logic, and technical documentation. Build and test solutions using AI agents and LLMs, troubleshoot data and system issues, support user acceptance and production validation, and partner with business stakeholders, data teams, product owners, and external technical resources to deliver maintainable enterprise systems.

Develop and deploy AI-enabled applications for global supply chain and sourcing workflows. Translate ambiguous business needs into production-ready applications, data pipelines, ontology objects, validation logic, and technical documentation. Build and troubleshoot AI agents and LLM solutions, integrate data and models, validate application behavior with stakeholders, support user acceptance testing, and resolve post-deployment issues. Collaborate with product owners, subject matter experts, data teams, and external technical partners to deliver scalable, maintainable solutions in a regulated environment.

Leads supplier quality improvement for metal components, including supplier audits, capability assessments, corrective actions, acceptance criteria, field-failure investigations, and manufacturing yield improvements. Partners with sourcing, engineering, manufacturing, testing, and quality teams on supplier projects and quality-system improvements. Ensures compliance with medical-device regulations and quality policies while influencing suppliers and cross-functional stakeholders.

Support attorneys on business development transactions from inception through post-closing: manage, draft, review, and track transactional and ancillary documents; coordinate external advisors; build playbooks, checklists, and AI-driven tools to streamline transaction workflows and post-acquisition obligations; manage timelines and deliverables using technology and independent judgment.

Designs and deploys applied AI solutions for regulated engineering workflows. Translates requirements from R&D subject matter experts into testable solution designs, evaluates tools and integration patterns, leads pilot design and validation, defines success criteria, and supports production handoff. The role develops retrieval-augmented generation, context engineering, and model integration patterns while coordinating AI architects, delivery teams, and engineering stakeholders across multiple disciplines.

Designs, builds, and operates production data pipelines supporting AI-enabled engineering workflows. Owns data curation, indexing quality, pipeline reliability, schemas, governance, metadata, lineage, and data-quality controls. Partners with AI, IT, and engineering teams to integrate systems such as Windchill, Jira, GitLab, and AWS. Supports retrieval-augmented generation, agentic workflows, evaluation harnesses, and production scaling in a regulated medical-device R&D environment.

Administer and support enterprise AI platform environments across multiple cloud and data platforms. Responsibilities include tenant onboarding, cloud resource provisioning, IAM and RBAC, AI service enablement, infrastructure automation, CI/CD, monitoring, incident response, reliability, disaster recovery, cost governance, documentation, and compliance support in a regulated enterprise environment.

Leads the AIS Mobile Monitor engineering team while contributing hands-on to Android and/or iOS medical software development. Responsibilities include people leadership, mentoring, budgeting, resource planning, technical strategy, automated testing, design and code reviews, regulatory compliance, cross-functional collaboration, and senior stakeholder communication. The manager will develop BLE-intensive mobile applications and support formal verification and integration of regulated medical-device software.