Senior Manufacturing Process Development Engineer

Senior Manufacturing Process Development Engineer at Abbott Vascular in St. Paul, Minnesota. This specialist role involves designing and developing manufacturing processes for vascular devices, managing technology transfer from research to production, and ensuring compliance with medical device regulations.

Responsibilities

• Design and develop manufacturing processes for vascular medical devices, addressing technology transfer challenges
• Develop procedures for economical mass production in coordination with pilot and production teams
• Conduct tests and measurements to ensure production control and validate critical variables
• Troubleshoot and resolve production process issues with existing equipment and operations
• Recommend acquisition of new technological equipment and materials to improve manufacturing

Requirements

• Bachelor's degree in engineering or technical discipline (mechanical, chemical, electrical, physics preferred)
• Minimum 4 years of relevant manufacturing process development experience
• Strong knowledge of medical device regulations (ISO 13485, FDA, GxP compliance)
• Expertise in mechanical or chemical engineering with excellent communication skills
• Experience with design controls, tolerance analysis, and statistical analysis
• Proficiency in cost-effective design and manufacturing of high-volume products

Compensation: $78,000–$156,000 base