
Senior Manager Manufacturing Engineering
- West Hills, CA
- Permanent
- Full-time
- Develop and implement a world-class automation roadmap for diagnostic product manufacturing.
- Provide technical leadership for the selection and integration of physical automation platforms (e.g., robotic liquid handling systems, industrial filling and packaging, robotic packaging, SCADA).
- Champion standardization, modularity, and scalability of automation solutions.
- Lead, train, and mentor the team through Practical Process Improvement (PPI).
- Identify areas for improvement and cost savings through equipment lifecycle management.
- Coordinate end-to-end automation projects—from concept, justification, timelines, budgets, prioritisation, URS generation, vendor selection, design/build, FAT/SAT, installation, CQV (commissioning, qualification, and validation).
- Drive improvements in efficiency, repeatability, and data integrity through automation upgrades or new installations.
- Lead, mentor, and develop a multidisciplinary team of automation and process engineers, technicians, and system integrators.
- Define performance objectives, training needs, and career development plans for the team.
- Ensure the team, process, and systems align with applicable regulations (FDA, 21 CFR Part 820, Part 11, ISO 13485, IVDR, ISO 17025).
- Own or support equipment/software validation protocols and risk assessments (e.g., FMEA).
- Support internal and external audits (e.g., FDA, Notified Bodies).
- Partner with R&D and Manufacturing Sciences to enable design-for-automation in new product development.
- Collaborate with QA, IT, and CSV teams to ensure systems are qualified, maintained, and detailed appropriately.
- Support tech transfer and scale-up activities by integrating automation into new or existing production lines.
- Bachelor’s or master’s in engineering (e.g., Electrical, Mechanical, Automation, or equivalent).
- 8+ years of experience in automation engineering, with 5+ years in people management roles.
- Demonstrated experience with automation in diagnostics, medical devices, or life sciences manufacturing.
- Project management experience a plus.
- Process Engineering experience a plus.
- Six Sigma experience a plus.