Catheter Manufacturing Process Engineer - Hands-On Impact

Skyline Search Partners; Minnesota; On-site; USD 85,000 - 115,000; Full time

Job summary

Skyline Search Partners partners with a growing medical device organization to hire a Manufacturing / Process Engineer specializing in catheter-based devices. The role emphasizes developing, validating, and transferring manufacturing processes for catheter products in a quality-driven environment.

You'll work hands-on on process tooling, validation activities, and design transfer, collaborating with Product Development, Quality, Operations, and suppliers to scale new catheter technologies from

Qualifications

• Bachelor's degree in Mechanical or Biomedical Engineering.
• 3–5+ years of medical device design, manufacturing, or process-development experience.
• Experience developing and improving medical-device manufacturing processes.
• Familiarity with FDA quality requirements and ISO 13485.
• Experience with process validation and regulated manufacturing documentation.
• Strong mechanical aptitude and hands-on problem-solving ability.
• Ability to work effectively across Engineering, Quality, Manufacturing, and Operations teams.
• Strong ownership, initiative, and ability to drive projects with limited oversight.

Responsibilities

• Develop, validate, and transfer manufacturing processes for catheter-based medical devices.
• Optimize existing processes for quality, throughput, yield, and cost.
• Identify opportunities for process innovation and continuous improvement.
• Apply Lean and Six Sigma to reduce variation and improve performance.
• Troubleshoot manufacturing and process issues and support production operations.
• Develop and support IQ/OQ/PQ protocols and process validation activities.
• Create and maintain Manufacturing Process Instructions (MPIs).
• Contribute to process documentation like PFMEAs and Control Plans.
• Establish calibration and preventive-maintenance requirements.
• Work with Product Development to transfer new products into manufacturing.
• Support prototype development, verification, validation, and risk assessment.
• Evaluate design transfer feasibility for scalable production.

Skills

Mechanical aptitude

Problem solving

Cross-functional collaboration

Ownership

Lean Six Sigma

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Job description

Skyline Search Partners partners with a growing medical device organization to hire a Manufacturing / Process Engineer specializing in catheter-based devices. The role emphasizes developing, validating, and transferring manufacturing processes for catheter products in a quality-driven environment.

You'll work hands-on on process tooling, validation activities, and design transfer, collaborating with Product Development, Quality, Operations, and suppliers to scale new catheter technologies from