Senior Operations Process Engineering Lead — Surgical Robotics

Johnson & Johnson Co.; Santa Clara (CA); On-site; USD 118,000 - 179,000; Full time

Job summary

Johnson & Johnson in Santa Clara is hiring an Operations Process Engineering Manager for OTTAVA to establish and lead a high-growth manufacturing engineering function for regulated capital equipment.

You will translate product and business requirements into capable manufacturing processes, own process ownership, validation, and continuous improvement. The role requires hands-on leadership and risk-based decision making across multiple functions.

Qualifications

• Bachelor's degree in mechanical, manufacturing, industrial, systems, biomedical or related engineering discipline.
• Minimum eight years in process/manufacturing engineering or development for complex electromechanical products.
• Experience in a regulated medical-device manufacturing environment with ISO 13485 and FDA QMS knowledge.
• Experience owning processes across transfer, validation, scale-up, and sustainment.
• Strong technical skills in assembly-process design, tooling, tolerance analysis, and production testing.
• Experience with PFMEA, control plans, process capability, and CAPA.

Responsibilities

• Lead the Operations Process Engineering function with ownership, governance, and escalation paths for manufacturing processes.
• Own end-to-end manufacturing processes in partnership with Operations, Quality, R&D, and Supply Chain.
• Provide technical direction for mechanical, electromechanical, assembly, test, calibration issues.
• Lead investigations with documented root cause, containment, corrective actions, and lessons learned.
• Plan and oversee process validation, equipment qualification, and change control.
• Represent Operations Process Engineering in governance, audits, and technical reviews.

Skills

Leadership

Regulated environment

PFMEA

CAPA

Root cause analysis

Problem solving

Cross-functional communication

Education

Bachelor's degree in engineering

Master's degree preferred

Tools

PFMEA

Control plans

CAPA tracking

Statistical methods

Job description

Johnson & Johnson in Santa Clara is hiring an Operations Process Engineering Manager for OTTAVA to establish and lead a high-growth manufacturing engineering function for regulated capital equipment.

You will translate product and business requirements into capable manufacturing processes, own process ownership, validation, and continuous improvement. The role requires hands-on leadership and risk-based decision making across multiple functions.