Jobs at Ortho Clinical Diagnostics

Lead design and implementation of database schemas and modular middleware for Linux-based devices using modern C++. Drive architecture, ensure data integrity, performance tuning, migrations, backup/recovery, testing, and observability within a regulated environment.

Develop and enhance Salesforce solutions across the full development lifecycle. Build Apex logic and Lightning Web Components, integrate external systems through APIs, optimize SOQL/SOSL queries, translate business requirements into technical designs, write tests, conduct code reviews, and collaborate with stakeholders in an Agile environment.

Owns end-to-end software release planning, coordination, risk management, integration, readiness, deployment, and continuous improvement for regulated medical device systems. The role manages schedules, budgets, resources, vendors, dependencies, Agile metrics, audit documentation, and cross-functional stakeholders across engineering, quality, regulatory, product, and operations. It also coaches teams in Scrum and ensures compliance with FDA, ISO 13485, IEC 62304, and internal design controls.

Leads development and manufacturing transfer of point-of-care diagnostic products, including consumables, instruments, assay integration, process scale-up, validation, documentation, and troubleshooting. Partners with scientists, manufacturing, quality, regulatory, and external design teams to ensure products are robust, compliant, cost-effective, and launch-ready. Provides technical guidance, manages project updates, improves processes, and supports design control activities in a regulated environment.

Designs, optimizes, and transfers manufacturing processes for diagnostic reagents and related products. Leads process improvement initiatives, applies Lean/Six Sigma, conducts risk and root-cause analyses, verifies process capability, and maintains quality-system records. Collaborates with scientists, engineers, quality teams, operations, technology transfer groups, and suppliers. The role includes laboratory work, technical project leadership, mentoring, and maintaining expertise in surface modification, formulation, and coating.

Supports HR operations for a manufacturing and operations team by handling employee relations, investigations, HR inquiries, Workday transactions, data integrity, interviews, unemployment claims, and employment-law compliance. Partners with HR functions and managers, manages multiple priorities, and supports HR projects. The role is hybrid in Rochester, New York, with four days onsite and travel between Rochester locations.

Supports product validation, root-cause and non-conformance investigations for transfusion medicine products. Performs diagnostic assay testing, quantitative analysis, validation documentation, quality audits, equipment maintenance, calibrations, and process or product change documentation. Collaborates with quality, regulatory, manufacturing, engineering, and laboratory teams while maintaining reagents, equipment, and compliance with cGMP requirements.

Owns demand planning and forecasting for assigned regions, countries, and diagnostic products. Responsibilities include collecting and analyzing sales forecasts, supporting demand planning and S&OP meetings, maintaining SAP/APO planning processes and parameters, coordinating supply with global planning teams, managing inventory targets, reducing obsolete stock, communicating new product launches, monitoring KPIs, and contributing to supply chain improvement projects.

Lead software testing and verification for embedded medical instrument systems, including end-to-end workflows across instrument functionality, device configuration, cloud connectivity, and interoperability. Develop test strategies, plans, cases, and automation-ready suites; execute and troubleshoot automated testing; and collaborate with engineering, quality, regulatory, project management, and external development teams. Support risk-based coverage, design controls, FDA-regulated documentation, effort estimation, and quality compliance.

Develop and execute North American marketing strategies, campaigns, positioning, messaging, and commercialization programs for laboratory automation solutions and services. Drive lead generation, customer adoption, retention, sales enablement, and pipeline growth. Conduct market and competitive analysis, gather customer insights, manage field marketing initiatives, and track Salesforce metrics, KPIs, forecasts, and ROI. Collaborate with sales, service, global marketing, and cross-functional teams while ensuring regulatory and branding compliance.

Lead North America commercialization for Informatics and digital health: translate global strategy into regional go-to-market plans, drive launches, sales enablement, customer adoption, partnerships evaluation, and cross-functional commercialization activities to grow product adoption and revenue in clinical labs and health systems.

Designs and builds scalable Azure data pipelines, integrates structured and unstructured sources, and provisions data into Lakehouse architectures. Develops with Azure Data Factory and Databricks, implements batch and streaming processing, applies business logic, optimizes large datasets, and supports legacy database migrations to cloud platforms. Collaborates in Agile teams to deliver trusted data solutions for analytical users.

The Trade Compliance Analyst will ensure compliance with international trade laws, develop trade processes, assess regulatory changes, and manage export compliance activities across JAPAC.

Leads global quality strategy for IVD assay design transfer and technology transfer into manufacturing. Partners with R&D, Quality, Operations, and Tech Transfer teams to ensure regulatory compliance, process readiness, risk management, verification and validation, and manufacturability. Interprets ISO, FDA, and IVDR requirements; supports inspections; identifies systemic quality risks; drives continuous improvement; and mentors engineers. The role is onsite in Rochester or Raritan, with occasional travel.

Own strategy and execution of integrated customer engagement programs across lines of business. Lead experience center, demo, and reference site programs; manage events, budgets, vendors, KPIs, and cross-functional coordination to drive adoption and commercial growth.

The Senior Global Procurement Lead will direct supplier selection, develop commodity strategies, ensure compliance, and partner with various departments to improve supply chain operations.

Manage assigned supplier relationships to ensure quality, cost, and delivery targets. Track and analyze supplier performance, maintain scorecards and dashboards, coordinate issue resolution and corrective actions, support RFIs/RFPs and contract administration, and partner with Supply Chain, Quality, R&D, Finance and Legal to maintain supply continuity and drive continuous improvement.

The Sales Manager will lead business development and sales activities in Calabria and Sicily, ensuring sales growth and strong customer relationships. Key responsibilities include achieving sales objectives, managing teams, coordinating agencies, and supporting seller negotiations.