MedTech Operations Process Leader

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

Job summary

Johnson & Johnson is seeking an Operations Process Engineering Manager for OTTAVA in Santa Clara. The role leads the process engineering function for regulated medical capital equipment, translating product needs into scalable manufacturing processes and owning risk‑based decisions with cross‑functional partners.

The ideal candidate combines hands‑on leadership with expertise in validation, PFMEAs, control plans, and manufacturing readiness to industrialize, sustain, and improve complex surgical

Qualifications

• Bachelor's degree in engineering required.
• 8+ years in process/manufacturing engineering roles.
• Experience in ISO 13485 and FDA QMS under 21 CFR Part 820 required.

Responsibilities

• Lead the OTTAVA Operations Process Engineering function with clear ownership and governance.
• Own end-to-end manufacturing processes in partnership with Operations, Quality, R&D, and Supply Chain.
• Provide technical direction for complex mechanical and electromechanical issues and investigations.
• Establish and maintain process controls, validation plans, and change controls.
• Represent Operations Process Engineering in cross-functional governance and reviews.

Skills

Process engineering

Leadership

Regulated medical device

Cross-functional collaboration

Education

Bachelor's degree in mechanical or related engineering

Job description

Johnson & Johnson is seeking an Operations Process Engineering Manager for OTTAVA in Santa Clara. The role leads the process engineering function for regulated medical capital equipment, translating product needs into scalable manufacturing processes and owning risk‑based decisions with cross‑functional partners.

The ideal candidate combines hands‑on leadership with expertise in validation, PFMEAs, control plans, and manufacturing readiness to industrialize, sustain, and improve complex surgical