Head of Engineering, Regulated Life Sciences Manufacturing

BD; Milpitas (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

BD in Milpitas, CA, seeks a seasoned Site Engineering Leader to oversee manufacturing engineering, sustaining engineering, and technical support, driving safety, quality, delivery, and cost targets. You will partner with Operations and R&D to transfer new Biosciences instruments to manufacturing, manage capital projects, and lead cost‑reduction initiatives while mentoring a diverse team.

This role requires 10–12+ years in engineering, 4+ years of people management, and experience in regulated

Qualifications

• Bachelor’s degree in Engineering or related field.
• 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.
• Experience working cross‑functionally with Operations, Quality, Supply Chain, and R&D.
• Excellent communication, leadership, and problem‑solving skills.

Responsibilities

• Lead, manage, and develop the site engineering organization.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Ensure engineering activities comply with quality systems and regulatory requirements (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.
• 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.

Skills

Engineering leadership

Manufacturing experience

Project management

Cross-functional collaboration

Communication

Education

Bachelor’s degree in Engineering or related field

Job description

BD in Milpitas, CA, seeks a seasoned Site Engineering Leader to oversee manufacturing engineering, sustaining engineering, and technical support, driving safety, quality, delivery, and cost targets. You will partner with Operations and R&D to transfer new Biosciences instruments to manufacturing, manage capital projects, and lead cost‑reduction initiatives while mentoring a diverse team.

This role requires 10–12+ years in engineering, 4+ years of people management, and experience in regulated