Senior Medical Device Process Engineer – Manufacturing & Validation

Abbott (abbottcareers2 board); United States; On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Free medical coverage in HIP PPO

High employer retirement contribution

Tuition reimbursement

FreeU education benefit

Job summary

Abbott in Temecula, CA, is seeking an engineer to develop new manufacturing processes and equipment for medical devices. You will work in the Abbott Vascular Devices division, ensuring regulatory compliance and quality standards.

The role requires strong engineering expertise, cross-functional collaboration, and experience with design controls, GxP, ISO, and FDA guidelines in a development/manufacturing setting.

Qualifications

• Bachelor's degree in Engineering or technical discipline.
• Master's degree is ideal.
• Minimum 4 years relevant engineering experience.
• Strong knowledge of design controls and medical device regulations (ISO 13485, FDA).
• Experience in mechanical or chemical engineering with strong communication skills.
• Familiarity with FDA/GxP, ISO and processes for development/manufacturing of medical devices.

Responsibilities

• Specify, design, verify and validate new manufacturing processes/equipment per medical standards.
• Troubleshoot process equipment; optimize processes.
• Develop process/product specs; conduct pFMEAs, DOEs; prepare validation docs.
• Communicate effectively; participate in cross-functional teams.
• Lead design reviews for equipment and product requirements.
• Submit Engineering Change Orders as required.
• Maintain effectiveness of the quality system.
• Develop and implement new processes following FDA guidelines.

Skills

Mechanical engineering

Chemical engineering

Good communication

Cross-functional teamwork

Process optimization

Statistical analysis

Education

Bachelor's Degree in Engineering/Technical field

Master's Degree (ideal)

Tools

pFMEAs

DOEs

Job description

Abbott in Temecula, CA, is seeking an engineer to develop new manufacturing processes and equipment for medical devices. You will work in the Abbott Vascular Devices division, ensuring regulatory compliance and quality standards.

The role requires strong engineering expertise, cross-functional collaboration, and experience with design controls, GxP, ISO, and FDA guidelines in a development/manufacturing setting.