MedTech Operations Process Engineering Leader

Biopharma Asia; Santa Clara (CA); On-site; USD 118,000 - 179,000; Full time

Job summary

Johnson & Johnson RAD (Robotics and Digital) seeks an Operations Process Engineering Manager – OTTAVA, for Santa Clara. This role leads the OTTAVA Operations Process Engineering function, translating product and business requirements into capable, controlled manufacturing processes and guiding a team through validation, readiness, and continuous improvement.

The ideal candidate combines process engineering rigor with leadership of engineers, risk-based decision making, and a hands-on approach to

Qualifications

• Bachelor’s degree in engineering or related field.
• 8+ years in process/manufacturing engineering for complex mechanical/electromechanical products.
• Experience in regulated medical-device manufacturing and knowledge of quality systems.

Responsibilities

• Lead end-to-end manufacturing processes with cross-functional partners.
• Drive process validation, equipment qualification, and change control.
• Manage investigations, CAPAs, and risk-based process controls.
• Provide technical direction for complex mechanical and electromechanical issues.

Skills

Process engineering

Leadership

Risk-based controls

QA/Regulatory knowledge

Education

Bachelor’s degree in engineering

Tools

SolidWorks

Job description

Johnson & Johnson RAD (Robotics and Digital) seeks an Operations Process Engineering Manager – OTTAVA, for Santa Clara. This role leads the OTTAVA Operations Process Engineering function, translating product and business requirements into capable, controlled manufacturing processes and guiding a team through validation, readiness, and continuous improvement.

The ideal candidate combines process engineering rigor with leadership of engineers, risk-based decision making, and a hands-on approach to