Senior Manufacturing Process Development Engineer – Medical Devices

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

Job summary

Abbott is seeking a Specialist in Manufacturing Process Development at the St. Paul, MN location within Abbott Vascular Devices.

The role focuses on designing and developing manufacturing processes for life sciences products, ensuring scalable, compliant solutions and efficient production transfer. The ideal candidate has a strong engineering background, 4+ years of relevant experience, and knowledge of ISO/FDA regulations, with a track record in process optimization and cross-functional

Qualifications

• Solid knowledge of general Engineering principles
• Strong understanding of design controls and regulatory requirements (FDA, ISO)
• Experience with statistical analysis and tolerance analysis
• Experience in development/manufacturing of medical devices
• Knowledge of GMP/GxP in FDA-regulated environment
• Cross-functional team collaboration experience

Responsibilities

• Design and develop manufacturing processes for life sciences products
• Develop procedures for economical mass production with pilot-plant and production teams
• Conduct tests to control process variables and ensure quality
• Troubleshoot and resolve production process problems
• Assess needs for new equipment/materials and make recommendations
• Ensure compliance with regulatory factors across projects

Skills

Engineering principles

Design controls

Statistical analysis

Tolerance analysis

Manufacturing process development

Education

Bachelor's in Engineering/Technical field

Master's degree (ideal)

Job description

Abbott is seeking a Specialist in Manufacturing Process Development at the St. Paul, MN location within Abbott Vascular Devices.

The role focuses on designing and developing manufacturing processes for life sciences products, ensuring scalable, compliant solutions and efficient production transfer. The ideal candidate has a strong engineering background, 4+ years of relevant experience, and knowledge of ISO/FDA regulations, with a track record in process optimization and cross-functional