Senior Manufacturing Process Engineer - Medical Devices

Thornton Tomasetti; Temecula (CA); Hybrid; USD 78,000 - 156,000; Full time

Benefits offered by this job

Free medical coverage (HIP PPO)

High employer contribution retirement

Tuition reimbursement and FreeU

Job summary

Abbott in Temecula, CA is seeking a Senior Manufacturing Process Engineer to develop and validate manufacturing processes and equipment for vascular devices. The role involves solving complex process problems, executing DOEs and fMEAs, and ensuring adherence to FDA and ISO standards.

The ideal candidate has a mechanical or chemical engineering background, 4+ years of experience, and strong communication skills to work with cross-functional teams in a regulated environment.

Qualifications

• Bachelor's Degree (±16 years) in Engineering/Technical Discipline (Mechanical, Chemical, Electrical or Physics preferred)
• Master's Degree (±18 years)
• Minimum 4 years relevant experience in engineering/manufacturing
• Strong knowledge of design controls and regulations for medical device development (ISO13485, FDA)

Responsibilities

• Specify, design, verify and validate new manufacturing processes and equipment; ensure compliance with medical regulatory standards
• Troubleshoot process equipment and perform process optimization
• Develop process/product specs; conduct pFMEAs, DOEs, validation protocols/reports; document per design control requirements
• Write and submit Engineering Change Orders as needed; maintain quality system effectiveness
• Lead cross-functional teams and participate in design reviews; ensure FDA and ISO compliance

Skills

Mechanical engineering

Chemical engineering

Regulatory compliance

Design controls

Communication skills

Education

Bachelor’s Degree in Engineering

Master’s Degree in Engineering or related field

Job description

Abbott in Temecula, CA is seeking a Senior Manufacturing Process Engineer to develop and validate manufacturing processes and equipment for vascular devices. The role involves solving complex process problems, executing DOEs and fMEAs, and ensuring adherence to FDA and ISO standards.

The ideal candidate has a mechanical or chemical engineering background, 4+ years of experience, and strong communication skills to work with cross-functional teams in a regulated environment.