Senior Principal Systems Engineering Excellence

Waters Corporation•Milford, MA

2d•Hybrid

About The Position

Our Center for Process Excellence team is on a mission to improve business outcomes and employee experiences by driving step-change improvements in critical enterprise processes, and the technology and analytics supporting these. As a Senior Principal Systems Engineering Excellence you will drive improvements in our R&D New Product Development (NPD) processes. This role will focus on enhancing systems engineering rigor, optimizing integration practices, and standardizing documentation templates (requirements, integration design planning, product concepts, etc.) to enable more efficient, compliant, and innovative product development. The SME will collaborate closely with R&D, Quality, Regulatory, and Product Management teams to design and implement best practices that accelerate development while ensuring scientific integrity and regulatory compliance.

Requirements

Bachelor’s or master’s in systems engineering, Biotechnology, Biomedical Engineering, or related technical discipline.
10+ years of experience in R&D systems integration, product design, or process excellence within biotech, medical devices, or life sciences.
Proven track record improving NPD processes and creating standardized templates for requirements and integration documentation.
Strong knowledge of systems engineering methodologies (e.g., INCOSE, V-model) and regulatory frameworks (e.g., FDA, ISO 13485).
Expertise in requirements management, integration planning, and design control.
Strong documentation and technical writing ability.
Familiarity with PLM systems, requirements management tools, and digital collaboration platforms.
Excellent facilitation and change management skills to align cross-functional teams.

Responsibilities

Assess current R&D NPD processes and identify opportunities for efficiency, quality, and compliance improvements.
Define and implement best-in-class systems engineering practices tailored to biotechnology product development.
Establish clear process interfaces across functions (R&D, Quality, Regulatory, Operations, Marketing).
Develop frameworks and templates for requirements management, system design planning, product concepts, and integration strategies.
Ensure effective traceability across requirements, design, verification, and validation.
Guide teams in applying systems thinking to complex biotech product architectures.
Create, update, and maintain standard document templates: User & system requirements System integration design planning Product concept & feasibility documentation Risk analysis, verification, and validation plans
Promote consistent documentation practices to improve knowledge transfer and regulatory readiness.
Partner with R&D scientists, engineers, program managers, and regulatory experts to embed system integration principles in daily work.
Provide coaching, training, and mentoring on best practices in requirements, design, and integration documentation.
Benchmark industry standards and introduce digital tools (e.g., PLM, requirements management systems) to streamline documentation and design workflows.
Act as a thought partner in shaping the future of R&D operations, enabling scalability and faster time-to-market.