Waters Corporation · 17 hours ago
Senior Principal Systems Engineering Excellence
Milford, MA
Full-time
Hybrid
Senior Level, Lead/Staff
10+ years expWaters Corporation is a global leader in analytical instruments and technologies, and they are seeking a Senior Principal Systems Engineering & Process Excellence Analyst to enhance their R&D New Product Development processes. This role focuses on improving systems engineering rigor, optimizing integration practices, and standardizing documentation to enable efficient and compliant product development.
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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
Qualification
Required
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
Company
Waters Corporation
Waters Corporation creates business advantages for laboratory-dependent organizations by delivering ultra performance liquid chromatography.
5001-10000 employees
H1B Sponsorship
Waters Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (30)
2023 (26)
2022 (13)
2021 (23)
2020 (15)
Funding
Current Stage
Public CompanyTotal Funding
$6MKey Investors
IDA Ireland
2022-10-07Grant· $6M
1995-11-24IPO
1994-08-01Private Equity
Leadership Team
Udit Batra
President and Chief Executive Officer
Recent News
2025-12-24
2025-12-11
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