Senior Automation Engineer, Medical Device Manufacturing

Cypress HCM; Irvine (CA); On-site; USD 115,000 - 145,000; Full time

Job summary

Cypress HCM in Irvine, CA seeks a manufacturing/automation engineer with 7+ years in regulated environments to own equipment from installation through qualification and sustaining support. You will drive change control, lifecycle maintenance, and cross‑functional collaboration to assure compliant processes.

Responsibilities include creating URS and technical requirements, supporting validation protocols, and working with automated or semi-automated assembly, testing, or inspection equipment.

Qualifications

• Bachelor’s degree in mechanical, manufacturing, electrical, mechatronics or related engineering field.
• 7+ years in automation, equipment or manufacturing engineering in regulated environments.
• Ownership of manufacturing equipment through installation, qualifications, sustaining support and change control.
• Experience with URS, technical requirements and validation protocols.
• Experience with automated or semi-automated assembly, testing or inspection equipment.
• Ability to read mechanical drawings, electrical schematics and pneumatic diagrams.
• Strong troubleshooting, technical writing, project management and cross-functional communication skills.
• Working knowledge of FDA, GMP, ISO 13485, risk management and change control.

Responsibilities

• Own manufacturing equipment through installation, qualification and sustaining support.
• Lead change controls and maintain equipment lifecycle documentation.
• Collaborate cross-functionally to ensure device compliance and process validation.
• Develop URS and technical requirements and support validation activities.

Education

Bachelor’s degree in Mechanical, Manufacturing, Electrical, Mechatronics, or a related engineering discipline.

Tools

SolidWorks

Job description

Cypress HCM in Irvine, CA seeks a manufacturing/automation engineer with 7+ years in regulated environments to own equipment from installation through qualification and sustaining support. You will drive change control, lifecycle maintenance, and cross‑functional collaboration to assure compliant processes.

Responsibilities include creating URS and technical requirements, supporting validation protocols, and working with automated or semi-automated assembly, testing, or inspection equipment.