Job DescriptionPosition SummaryThe 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 ResponsibilitiesSite Engineering Leadership
- Lead, manage, and develop the site engineering organization, including manufacturing engineering, sustaining engineering, and technical support functions.
- Establish clear priorities, goals, and performance expectations aligned with site and business objectives.
- Build engineering capability, talent depth, and succession plans to support current and future business needs.
- Foster a culture of accountability, continuous improvement, collaboration, and high technical standards.
Manufacturing & Operations Support
- Provide overall technical leadership for manufacturing processes supporting Waters Biosciences instruments.
- Partner with Operations leadership to achieve safety, quality, delivery, and cost targets.
- Support manufacturing throughput, yield improvement, cycle time reduction, and product reliability initiatives.
- Ensure engineering support for day-to-day production, system and sub-assembly testing, and issue resolution.
- Lead or support capital equipment justification, selection, and implementation to improve productivity or replace obsolete assets.
Sustaining Engineering & Cost Reduction
- Own and execute the site's sustaining engineering portfolio, ensuring work is prioritized and aligned with business needs.
- Lead value engineering, redesign, PPV improvement, and cost-reduction initiatives for existing instrument platforms.
- Drive disciplined problem-solving using root cause analysis, CI, and Lean/Six Sigma methodologies.
- Ensure effective execution of ECOs, MRBs, and CAPAs in collaboration with Quality, Manufacturing, and R&D.
New Product Introduction & Technology Transfer
- Partner with R&D to support successful transfer of new Biosciences instruments into manufacturing.
- Ensure manufacturing readiness, including processes, tooling, documentation, test strategies, and training.
- Provide site representation in cross-functional NPI and platform governance forums.
- Support integration of acquisitions or new technologies into site manufacturing operations as required.
Product Lifecycle Governance
- Support product lifecycle management activities, including sustainment, transitions, and end-of-life execution.
- Participate in project proposal reviews, portfolio prioritization, and lifecycle decision-making forums.
- Ensure site engineering alignment with global lifecycle strategies for Waters instruments.
Supplier & Supply Chain Engineering Support
- Provide engineering support for supplier selection, qualification, and ongoing performance management.
- Partner with Supply Chain and Quality to address supplier quality issues and implement corrective actions.
- Ensure critical features, inspection points, and test requirements are defined and embedded in manufacturing and QC processes.
Technical Standards, Systems & Documentation
- Maintain ownership of engineering drawings, technical documentation, and drawing control systems at the site.
- Ensure compliance with engineering standards, design control requirements, and documentation practices.
- Develop and apply site-specific engineering frameworks and best practices aligned with global standards.
Quality, Regulatory & Safety Compliance
- Ensure engineering activities comply with applicable quality systems and regulatory requirements (e.g., FDA, ISO).
- Provide technical support for audits, inspections, and regulatory inquiries.
- Ensure adherence to EH&S requirements and promote a strong safety culture across all engineering areas.
- Support GMP, design control, change management, and risk management processes.
Financial & Operational Management
- Develop and manage site engineering budgets, forecasts, and operating plans.
- Provide cost estimates, run-rate analysis, and input to annual operating and strategic planning processes.
- Track and report engineering performance metrics to Operations and senior leadership.
QualificationsRequired
- Bachelor's degree in Engineering or a related technical discipline.
- 10-12+ years of progressive engineering experience in manufacturing, sustaining engineering, or product development.
- 4+ years of people management experience leading engineering teams in a manufacturing environment.
- Strong experience supporting electro-mechanical instrumentation or complex manufacturing systems.
- Demonstrated success managing multiple engineering projects in a regulated, matrixed environment.
- Experience working cross-functionally with Operations, Quality, Supply Chain, and R&D.
- Excellent communication, leadership, and problem-solving skills.
Preferred
- Master's degree, MBA, or advanced technical degree.
- PMP and/or Six Sigma (Black Belt or DFSS) certification.
- Experience in life sciences, biotechnology, diagnostics, or analytical instrumentation industries.
- Strong working knowledge of FDA, ISO 13485, GMP, and design control environments.
- Experience supporting global manufacturing or contract manufacturing partners.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
Primary Work LocationUSA CA - Milpitas 155
Salary Range Information$183,800.00 - $294,100.00 USD Annual
