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Senior Manufacturing Engineer - Medical Device

Job in Saint Paul, Ramsey County, Minnesota, 55199, USA
Listing for: Intellectt Inc
Full Time position
Listed on 2026-03-05
Job specializations:
  • Engineering
    Manufacturing Engineer, Quality Engineering
Salary/Wage Range or Industry Benchmark: 80000 - 100000 USD Yearly USD 80000.00 100000.00 YEAR
Job Description & How to Apply Below

Development Process Engineer supporting medical device delivery systems to the heart, including catheter-based products. Responsible for process development, equipment validation, line setup, yield improvement, and regulatory compliance in a highly matrixed environment.

Key Responsibilities
  • Establish processes based on product specifications and Design for Manufacturability (DFM)
  • Run Design of Experiments (DOE) to improve yield and efficiency
  • Determine best manufacturing processes for shafts and delivery systems
  • Set up production lines (5–6 tooling/fixture tables)
  • Coordinate design, procurement, build, and debug of tooling, fixtures, and equipment
  • Conduct equipment qualifications and process validations
  • Write manufacturing procedures
  • Lead process improvements, cost reductions, and capacity increases
  • Apply Lean manufacturing and DMAIC methodologies
  • Manage compliance with Design Control, Process Validation, QMS, EMS
  • Ensure compliance with FDA, OSHA, IP, and regulatory requirements
  • Partner cross-functionally with R&D, Quality, Finance, and Operations
  • Coach and mentor technicians and operators
Required Qualifications
  • Bachelor’s Degree in Chemical, Industrial, Mechanical Engineering, or related field
  • 5+ years manufacturing engineering experience in medical device or related industry
  • Experience with catheter and delivery systems manufacturing
  • Strong analytical, project management, and problem-solving skills
  • Experience in matrixed, cross-division environments
  • Strong written and verbal communication skills
  • Detail-oriented, organized, results-driven, able to multitask and prioritize
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Position Requirements
10+ Years work experience
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