Senior Medical Device Process Development Engineer

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

Benefits offered by this job

Health insurance

Tuition reimbursement

Retirement plan

Job summary

Abbott Vascular in St. Paul, MN seeks a Specialist Manufacturing Process Development Engineer to design and develop manufacturing processes for life sciences products, translating research into scalable production.

You will collaborate with pilot-plant and production teams to optimize processes and ensure compliance with GxP, ISO 13485 and FDA requirements. The role demands a strong technical background in mechanical or chemical engineering, plus proficiency in calculations and statistical

Qualifications

• Bachelor's degree in engineering or related field with strong technical foundation.
• Experience applying design controls in medical device development.
• Solid understanding of GxP, ISO, and regulatory requirements for medical devices.

Responsibilities

• Design and develop manufacturing processes for life sciences products.
• Develop procedures for economical mass production with pilot-plant and production teams.
• Conduct tests and measurements to control production variables.
• Troubleshoot and resolve production process issues with existing equipment.

Skills

Engineering principles

GxP knowledge

ISO 13485 / FDA

Mechanical/Chemical engineering

Statistical analysis

Process development

Education

Bachelor's degree in Engineering

Master's degree

Job description

Abbott Vascular in St. Paul, MN seeks a Specialist Manufacturing Process Development Engineer to design and develop manufacturing processes for life sciences products, translating research into scalable production.

You will collaborate with pilot-plant and production teams to optimize processes and ensure compliance with GxP, ISO 13485 and FDA requirements. The role demands a strong technical background in mechanical or chemical engineering, plus proficiency in calculations and statistical