Principal Engineer, Process Development and Automation - Pre-Analytical

Principal Engineer, Process Development and Automation - Pre-Analytical at Exact Sciences summary:

The Principal Engineer, Process Development and Automation at Exact Sciences leads the design, implementation, and optimization of automated laboratory workflows and instrumentation in a regulated clinical environment. This role involves cross-functional collaboration to develop new automation systems, support product development, and ensure compliance with FDA, CLIA, and CAP standards. The engineer is also responsible for mentoring teams, troubleshooting complex systems, and driving continuous improvements to enhance lab efficiency and quality.

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Position Overview

The Principal Engineer, Process Development and Automation Engineer, manages, implements, and provides technical engineering support for a variety of process automation hardware, software applications, and laboratory instruments. This position works and collaborates cross functionally with internal and external partners to enhance existing workflows and develop new automated workflows in a complex, rapidly evolving clinical laboratory. The Principal Engineer, Process Development and Automation Engineer responsibilities may include guiding Lab Service, Process Development and Automation and Laboratory Operations teams in the process of selecting automation, system design, integration, commissioning, and project documentation.

This roles influence extends to the technical, quality, and business teams, as well as the other engineers within laboratory operations.

Essential Duties

include but are not limited to the following:

• Applies in-depth knowledge to key technical and testing activities; conceives and directs / conducts experiments, or engineering studies used to make significant tactical, strategic and compliance decisions.
• Collaborates and negotiates deliverables with other functional organizations.
• Develops complex process architectures and functional specifications based on user and workflow requirements. Plans and directs / conducts complex engineering design, platform eligibility testing, systems integration, and performance / validation testing.
• Provides expert input into technical decisions and recommendations.
• Solves unusual or highly technical/scientific problems.
• Provides input to senior management for making strategic & functional decisions.
• Helps senior management develop decision-making guidelines and problem-solving techniques.
• Communicates and influences decisions across multiple functional areas and platforms.
• Evaluates and sells alternative solutions, effectively influencing outcomes.
• Ability to work with Sr. Management on product development initiatives.
• Actively and constructively contributes to other’s designs through design reviews across multiple platforms.
• Facilitates reuse by communicating available technologies and opportunities across organizations.
• Ability to lead major project teams and major cross-organizational programs.
• Recognized as an expert resource on issues across projects and product lines.
• Role model in organization for project management, communication, and cross-group influence.
• Teaches and mentors others on technical and other development issues.
• Regularly demonstrates leadership behaviors: humility, will, best team and vision.
• Applies company knowledge and industry expertise to assist senior management with leading product development.
• Develops new products and technologies for emerging and existing markets.
• Work with project managers and cross-functional teams on user requirements, factory acceptance tests, validation planning, site acceptance tests, pre-installation planning, initial installation, setup, maintenance, and improvement for new or upgraded instrumentation and automation systems.
• Work with business stakeholders to define strategy and…