Manufacturing Engineer II

Posted: 01/09/2026 Location: Maple Grove, Minnesota, United States Salary: $75000 - $100000 Job type: Permanent


JOB TITLE: Manufacturing Engineer II

SHIFT: First Shift

LOCATION: Fully on-site


Role Purpose


The Manufacturing Engineer II provides technical ownership of assigned manufacturing processes on a catheter manufacturing line, ensuring compliant, efficient production while supporting continuous improvement and cross-functional problem solving.


Summary


This role is responsible for owning manufacturing processes on a single-use disposable device line, supporting equipment and process troubleshooting, and driving root cause analysis and corrective action. The role also supports operator training and cross-site process alignment. All engineering functions are responsible for compliance with the Quality System and applicable regulations and standards, continuous improvement, and professional interaction with internal and external partners as needed.


Duties and Responsibilities


Onboarding & Process Ownership

• Onboard into assigned processes through line walks, QSP review, and direct collaboration with operators
• Take ownership of assigned manufacturing processes and serve as the process subject matter expert

Documentation & Change Control

• Review and update manufacturing procedures (MPs) and travelers
• Route and manage change orders (COs) to update work instructions

Production Support & Continuous Improvement

• Collect and analyze yield and scrap data to identify trends
• Lead continuous improvement activities tied to process performance
• Serve as first line of technical response to line down situations before escalation

Quality & Root Cause Analysis

• Support root cause analysis and corrective action for nonconformances (NCMRs), partnering with the Quality team
• Support incoming inspection and on-line failure investigations as needed

Cross-Functional Support

• Support cross-site process alignment on shared manufacturing lines
• Train operators on tools, equipment, and processes

Supervisory Responsibilities


This job has no direct supervisory responsibility.


Qualifications


Required:

• Bachelor's degree in a life science, engineering, or related technical discipline, or an equivalent combination of education and experience
• 5+ years of experience in medical device development or manufacturing, or 3+ years of experience in a Design Assurance or Quality Engineering role (contract manufacturing environment experience preferred; candidates with 3+ years of hands-on catheter manufacturing experience will also be considered)
• Hands-on exposure to single-use disposable devices, including catheters, guidewires, and lumens
• Experience with ultrasonic welders, balloon bonders, and laser bonders
• General exposure to catheter manufacturing processes and equipment

Preferred:

• Electromechanical and test equipment experience
• Experience with braiding equipment
• Familiarity with root cause tools such as 5-Why and fishbone analysis

Soft Skills:

• Ability to work independently in a fast-paced, evolving environment
• Strong problem-solving skills and ownership mindset
• High attention to detail
• Strong communication skills, including the ability to work effectively with operators

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