Manufacturing Process Engineer – Catheter Medical Devices

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

We are partnering with a growing medical device design and manufacturing organization to hire a Manufacturing / Process Engineer specializing in catheter-based medical devices. The organization works at the intersection of medical device development and contract manufacturing, helping bring complex minimally invasive technologies from development into scalable production.

About the Role

This role will take significant ownership over the development, validation, optimization, and transfer of manufacturing processes supporting catheter product lines. You'll work closely with Product Development, Quality, Manufacturing, customers, and suppliers to ensure new products can be manufactured reliably, efficiently, and in compliance with medical-device quality requirements. We're looking for someone who enjoys being close to the manufacturing floor, solving problems, building processes and tooling, and taking ownership rather than waiting for someone else to provide the answer.

This is a hands-on engineering role in an environment where products, processes, and manufacturing methods continue to evolve. You'll help determine how complex catheter products are actually built at scale—developing manufacturing processes, designing tooling and fixtures, supporting validation, improving yield and throughput, and helping transition new products from development into production. Because the organization works with medical-device customers across different development programs, you'll also have exposure to a variety of technologies and engineering challenges rather than spending your career supporting a single mature product line.

Responsibilities

Manufacturing & Process Development

• Develop, implement, and validate manufacturing processes for catheter-based medical devices
• Optimize existing processes for quality, repeatability, throughput, yield, and cost
• Identify opportunities for process innovation and continuous improvement
• Apply Lean and Six Sigma methodologies to reduce variation and improve manufacturing performance
• Troubleshoot complex manufacturing and process issues
• Support production operations with technical engineering expertise

Process Validation & Documentation

• Develop and support IQ/OQ/PQ protocols and process validation activities
• Create and maintain Manufacturing Process Instructions (MPIs)
• Contribute to Inspection Plans, Lot History Records, Device Master Records, Process Flow Diagrams, PFMEAs, and Control Plans
• Establish calibration and preventive-maintenance requirements
• Maintain accurate engineering documentation throughout manufacturing development and transfer
• Ensure processes comply with applicable medical-device quality and regulatory requirements

Design Transfer & New Product Introduction

• Work closely with Product Development and other engineering resources to transfer new products into manufacturing
• Support prototype development, verification and validation, risk assessment, and performance testing
• Evaluate whether new designs can be manufactured reliably and efficiently
• Help bridge the gap between development-stage catheter technologies and commercial production

Tooling, Equipment & Automation

• Design and implement manufacturing tooling and fixtures
• Support selection and implementation of capital equipment
• Develop manufacturing solutions that improve repeatability and operator efficiency
• Work with outside vendors when specialized equipment or manufacturing capabilities are required
• Support qualification and implementation of new manufacturing technologies

Technical Leadership & Collaboration

• Work cross-functionally with Product Development, Quality, Operations, Manufacturing, suppliers, and customers
• Provide technical leadership within assigned manufacturing areas
• Communicate project progress, technical issues, and recommendations to internal and external stakeholders
• Train employees on manufacturing processes and applicable quality requirements
• Take ownership of engineering initiatives and drive projects toward completion

Qualifications

Required

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related discipline
• 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

Preferred

• Medical‑device contract manufacturing or CDMO experience
• Hands‑on experience with catheter‑based medical devices
• Familiarity with catheter design and extrusion processes
• Experience with reinforced shafts, delivery systems, and/or steerable catheters

Why This Opportunity

• Hands‑on catheter engineering: Work directly with complex minimally invasive medical-device manufacturing technologies
• Own the manufacturing process: Develop processes rather than simply maintaining established production
• Development‑to‑production exposure: Help move new catheter technologies from engineering into scalable manufacturing
• Technical variety: Support multiple products and customer programs
• Real process ownership: Drive validation, tooling, yield, throughput, cost, and continuous improvement
• Customer exposure: Work with medical-device companies developing new technologies
• High‑impact environment: Individual engineers have meaningful ownership and visibility
• Growth opportunity: Expand technical leadership as the organization and its manufacturing capabilities continue to grow