Senior MedTech Manufacturing Process Engineer

Hardware FYI; Saint Paul (MN); On-site; USD 78,000 - 156,000; Full time

Job summary

Abbott is a global healthcare leader with a Vascular Devices division based in St. Paul, MN.

This Specialist role focuses on Manufacturing Process Development, designing and developing manufacturing processes for life sciences products and ensuring regulatory compliance, with a strong emphasis on cost-effective, scalable production. Ideal candidates bring 4+ years in engineering, strong knowledge of ISO13485/FDA, and a track record of working in cross-functional teams to bring complex devices to

Qualifications

• Bachelor's Degree in Mechanical, Chemical, Electrical or Physics or equivalent.
• Master's Degree preferred.
• Minimum 4 years of relevant experience.
• Strong knowledge of design controls and medical device regulations (ISO134851, ISO13485, FDA).
• Strong technical experience in mechanical or chemical engineering with good written and verbal communication.
• Understanding of processes and materials for medical devices, especially diabetes strips.
• Experience in development in FDA regulated environment with GxP.
• Cross-functional team collaboration.

Responsibilities

• Design and develop manufacturing processes for life sciences products.
• Develop procedures for mass production with pilot-plant and production.
• Conduct tests to control production variables.
• Troubleshoot and solve production process problems.
• Advise on new equipment and materials.
• Ensure compliance with regulatory factors.

Skills

Mechanical engineering

Chemical engineering

Statistical analysis

Design for manufacture

Written communication

Verbal communication

Cross-functional teams

FDA regulations

GxP knowledge

ISO 13485

Education

Bachelor's degree in engineering/technical discipline

Master's degree

Job description

Abbott is a global healthcare leader with a Vascular Devices division based in St. Paul, MN.

This Specialist role focuses on Manufacturing Process Development, designing and developing manufacturing processes for life sciences products and ensuring regulatory compliance, with a strong emphasis on cost-effective, scalable production. Ideal candidates bring 4+ years in engineering, strong knowledge of ISO13485/FDA, and a track record of working in cross-functional teams to bring complex devices to