Senior Manufacturing Engineering Manager - Medical Devices

Abbott; Pleasanton (CA); On-site; USD 114,000 - 228,000; Full time

Job summary

Abbott in Pleasanton, CA is seeking a Manufacturing Engineering Manager to lead planning and execution of manufacturing and production engineering projects. You will design and develop manufacturing processes, tooling & fixture design and process development products to meet daily production and new product schedules while improving productivity and quality.

This role requires strong leadership, cross-functional collaboration, and adherence to FDA, GMP, and ISO standards.

Qualifications

• BS in Engineering; advanced degree preferred.
• 10 years manufacturing/process development experience with minimum 5 years of technical staff management and 3 years of cross-functional project management.
• 5 years prior experience in medical device manufacturing preferred.
• Experience with statistical techniques (e.g., DOE, SPC).
• Experience with Lean manufacturing techniques, value stream mapping, and continuous improvement methodologies.
• Solid people management and communication skills.
• Solid knowledge of GMP, ISO regulations.
• Demonstrated success in leading mfg technology transfer projects to global operations.
• Experience working in a broader enterprise/cross division business unit model preferred.
• Ability to travel approximately 10%, including internationally.

Responsibilities

• Provide leadership to engineering staff regarding project prioritization, process validations, and continuous improvement activities.
• Implement and manage resource planning and project management tools.
• Collaborate with Manufacturing Engineering Department managers in selecting and scheduling project engineers for Operations projects.
• Support continuing production, process development and new product introductions.
• Monitor and evaluate project and department progress and results.
• Participate in cross-functional teams.
• Review and approve protocol and written reports.
• Drive continuous improvement of engineering technical capabilities.
• Prepare technical reports, analysis, recommendations and presentations reflecting the status and results of projects in progress on a regular basis.
• Coach, manage and develop technical staff.
• Develop, implement, train and monitor effectiveness of engineering systems and procedures to ensure compliance to FDA, GMP and all other applicable agency regulations.
• Ensure a safe work environment consistent with OSHA requirements and Abbott Policies.
• Prepare departmental budgets and control expenditures to stay within spending limits.
• Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Skills

Leadership

Project management

Manufacturing engineering

Staff management

Lean manufacturing

DOE/ SPC

GMP/ISO

Cross-functional collaboration

Communication

Education

Bachelor of Science in Engineering

Advanced degree preferred

Job description

Abbott in Pleasanton, CA is seeking a Manufacturing Engineering Manager to lead planning and execution of manufacturing and production engineering projects. You will design and develop manufacturing processes, tooling & fixture design and process development products to meet daily production and new product schedules while improving productivity and quality.

This role requires strong leadership, cross-functional collaboration, and adherence to FDA, GMP, and ISO standards.