Senior Medical Device Process Engineer – Impact & Growth

Thornton Tomasetti; United States; On-site; USD 78,000 - 156,000; Full time

Job summary

Abbott in Temecula, CA is seeking a process engineer to develop and optimize manufacturing processes for vascular devices. You will design, verify and validate equipment and processes in a regulated FDA environment.

The role requires strong analytical skills, experience with PFMEAs/DOEs, design controls, and cross-functional teamwork. Excellent communication and problem-solving are essential as you drive quality and efficiency.

Qualifications

• Bachelor's or Master’s in Engineering, relevant experience preferred.
• Regulatory knowledge: FDA, ISO13485, ISO134851/13485.

Responsibilities

• Specify, design, verify and validate new manufacturing processes and equipment per medical standards.
• Troubleshoot process equipment and perform process optimization.
• Develop process/product specifications, conduct PFMEAs, DOEs, validation protocols/reports and other documentation.
• Communicate effectively and participate on cross functional development teams.
• Maintain and improve quality system effectiveness through controlled change management.

Skills

Statistical analysis

Tolerance analysis

DFM

Cross-functional team

Regulatory knowledge

Education

Bachelor's Degree in Engineering

Master's Degree preferred

Job description

Abbott in Temecula, CA is seeking a process engineer to develop and optimize manufacturing processes for vascular devices. You will design, verify and validate equipment and processes in a regulated FDA environment.

The role requires strong analytical skills, experience with PFMEAs/DOEs, design controls, and cross-functional teamwork. Excellent communication and problem-solving are essential as you drive quality and efficiency.