Associate Director Engineering

Associate Director of Engineering

The Associate Director of Engineering is the senior engineering leader at the site level, responsible for engineering execution, technical governance, and performance. This role leads and manages site engineering functions supporting manufacturing, sustaining engineering, product lifecycle management, and operational excellence, while ensuring compliance with quality, regulatory, and safety requirements.

The Associate Director of Engineering partners closely with Operations, R&D, Quality, Supply Chain, and global engineering leadership to support instrument supply assurance, new product introductions (NPI), technology transfer, cost reduction initiatives, and product lifecycle governance. This role owns engineering delivery at the site, ensuring products are manufactured safely, compliantly, on time, and at target cost and quality.

Key responsibilities include:

• Leading, managing, and developing the site engineering organization, including manufacturing engineering, sustaining engineering, and technical support functions.
• Establishing clear priorities, goals, and performance expectations aligned with site and business objectives.
• Building engineering capability, talent depth, and succession plans to support current and future business needs.
• Fostering a culture of accountability, continuous improvement, collaboration, and high technical standards.
• Providing overall technical leadership for manufacturing processes supporting Waters Biosciences instruments.
• Partnering with Operations leadership to achieve safety, quality, delivery, and cost targets.
• Supporting manufacturing throughput, yield improvement, cycle time reduction, and product reliability initiatives.
• Ensuring engineering support for day-to-day production, system and sub-assembly testing, and issue resolution.
• Leading or supporting capital equipment justification, selection, and implementation to improve productivity or replace obsolete assets.
• Owning and executing the site's sustaining engineering portfolio, ensuring work is prioritized and aligned with business needs.
• Leading value engineering, redesign, PPV improvement, and cost-reduction initiatives for existing instrument platforms.
• Driving disciplined problem-solving using root cause analysis, CI, and Lean/Six Sigma methodologies.
• Ensuring effective execution of ECOs, MRBs, and CAPAs in collaboration with Quality, Manufacturing, and R&D.
• Partnering with R&D to support successful transfer of new Biosciences instruments into manufacturing.
• Ensuring manufacturing readiness, including processes, tooling, documentation, test strategies, and training.
• Providing site representation in cross-functional NPI and platform governance forums.
• Supporting integration of acquisitions or new technologies into site manufacturing operations as required.
• Supporting product lifecycle management activities, including sustainment, transitions, and end-of-life execution.
• Participating in project proposal reviews, portfolio prioritization, and lifecycle decision-making forums.
• Ensuring site engineering alignment with global lifecycle strategies for Waters instruments.
• Providing engineering support for supplier selection, qualification, and ongoing performance management.
• Partnering with Supply Chain and Quality to address supplier quality issues and implement corrective actions.
• Ensuring critical features, inspection points, and test requirements are defined and embedded in manufacturing and QC processes.
• Maintaining ownership of engineering drawings, technical documentation, and drawing control systems at the site.
• Ensuring compliance with engineering standards, design control requirements, and documentation practices.
• Developing and applying site-specific engineering frameworks and best practices aligned with global standards.
• Ensuring engineering activities comply with applicable quality systems and regulatory requirements (e.g., FDA, ISO).
• Providing technical support for audits, inspections, and regulatory inquiries.
• Ensuring adherence to EH&S requirements and promoting a strong safety culture across all engineering areas.
• Supporting GMP, design control, change management, and risk management…