Medical Device Manufacturing Engineer — Process Dev & Validation

Laborie Medical Technologies Corp; Plymouth (MN); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Paid time off

Medical, Dental, Vision

Health Savings Account

401k with company match

Parental Leave

Job summary

Laborie Medical Technologies Corp in Minnesota is seeking a Manufacturing Engineer to support process development, validation, and integration of medical device manufacturing. You will design, qualify, and optimize production lines for catheter balloon components, ensuring quality and efficiency in a controlled environment.

The role requires hands-on engineering experience, ability to travel up to 25%, and collaboration with vendors and operators to reduce defects and improve processes in a

Qualifications

• Bachelor’s degree and 5+ years in Manufacturing Process Engineering.
• Experience with statistical analysis methods for process development; Minitab preferred.
• Experience in chemical and process engineering.
• SolidWorks proficiency.
• Ability to travel up to 25%.
• Preferred catheter/balloon catheter experience; ISO 13485/ISO 9000; IQ/OQ/PQ experience; Six Sigma certification.

Responsibilities

• Evaluate and develop manufacturing processes; confer with vendors; observe operators.
• Oversee manufacturing process of catheter balloon components; tests and validation.
• Install and qualify manufacturing equipment including injection molding and balloon tooling.
• Plan and execute IQ/OQ/PQ; draft protocols/reports; perform PFMEA.
• Improve efficiency by analyzing workflow, space needs and layouts using statistics.
• Design and implement manufacturing fixtures and equipment.
• Support supervisor with production cost estimates and schedules.

Skills

Statistical analysis

Minitab

SolidWorks

Process engineering

Project planning

Education

Bachelor’s degree in Biomedical, Mechanical or Industrial engineering

Tools

Injection molding equipment

PFMEA / quality tools

Job description

Laborie Medical Technologies Corp in Minnesota is seeking a Manufacturing Engineer to support process development, validation, and integration of medical device manufacturing. You will design, qualify, and optimize production lines for catheter balloon components, ensuring quality and efficiency in a controlled environment.

The role requires hands-on engineering experience, ability to travel up to 25%, and collaboration with vendors and operators to reduce defects and improve processes in a