Senior Medical Device Process Engineer – Manufacturing

Abbott Laboratories; Temecula (CA); On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Free medical coverage

Retirement plan with high employer %

Tuition reimbursement

Job summary

Abbott is a global healthcare leader seeking a Manufacturing Process Engineer for the Temecula, CA site within the Abbott Vascular Devices division. You will develop new manufacturing processes and equipment, and address engineering challenges while collaborating with cross-functional teams to ensure quality and regulatory compliance.

The role emphasizes process design, validation, and continuous improvement in a FDA-regulated environment, with opportunities to contribute to Abbott's innovative

Qualifications

• Bachelor's degree in engineering or related technical discipline required.
• Master's degree preferred or equivalent experience.
• Minimum 4 years of relevant experience.
• Strong knowledge of design controls and regulations for medical device development (ISO13485, FDA).
• Strong communication and documentation skills are essential.
• Experience performing complex engineering calculations, tolerance analysis, and statistics.

Responsibilities

• Specify, design, verify and validate new manufacturing processes and equipment, in accordance with applicable medical regulatory standards.
• Troubleshoots process equipment and perform process optimization.
• Develops process/product specifications, conduct PFMEAs, DOEs, validation protocols/reports and other documentation following design control requirements.
• Communicate effectively and participate on cross functional development teams.
• Conducts or participates in technical design reviews for process equipment and product design and requirements documents.
• Write and submit Engineering Change Orders, as required.
• Responsible for utilizing and maintaining the effectiveness of the quality system.
• Development and implementation of new processes, equipment, materials, verification and validation. Follow FDA guidelines.

Skills

Engineering principles

Regulatory compliance

Process engineering

Cross-functional teamwork

Statistical analysis

Education

Bachelor's degree in Engineering/Technical discipline

Master's degree preferred

Job description

Abbott is a global healthcare leader seeking a Manufacturing Process Engineer for the Temecula, CA site within the Abbott Vascular Devices division. You will develop new manufacturing processes and equipment, and address engineering challenges while collaborating with cross-functional teams to ensure quality and regulatory compliance.

The role emphasizes process design, validation, and continuous improvement in a FDA-regulated environment, with opportunities to contribute to Abbott's innovative