Medical device Test Engineer

Katalyst CRO; Pittsburgh (Allegheny County); On-site; USD 70,000 - 100,000; Full time

Job summary

Katalyst CRO is seeking a Product Industrialization Test Engineer to help transition medical device products from design to manufacturing. You will develop, optimize, and industrialize test and production processes, focusing on improving manufacturing efficiency and applying Lean principles.

Requirements include at least 1 year in medical device manufacturing or related engineering testing, plus knowledge of compliance documentation, manufacturing processes, and basic programming skills.

Qualifications

• Bachelor's or Master's degree in Engineering (Electrical, Mechanical, Mechatronics, or related field) required.
• At least 1 year of experience in medical device manufacturing, engineering testing, or related functions.
• Knowledge of compliance documentation, manufacturing processes, and basic programming skills.

Responsibilities

• Execute test protocols.
• Maintain manufacturing data and Bills of Materials.
• Improve processes and contribute to continuous improvement initiatives in a regulated environment.
• Support transition of medical device products from design to manufacturing by developing, optimizing, and industrializing test and production processes.

Skills

Analytical thinking

Problem-solving

Communication

Documentation

Basic programming

Lean Manufacturing

Education

Bachelors or Masters degree in Engineering (Electrical, Mechanical, Mechatronics, or related field)

Job description

• The Product Industrialization Test Engineer supports the transition of medical device products from design to manufacturing by developing, optimizing, and industrializing test and production processes.
• The role focuses on improving manufacturing efficiency, implementing Lean Manufacturing principles, managing manufacturing documentation and Bills of Materials, and supporting process, tooling, and equipment enhancements.
• Responsibilities include executing test protocols, ensuring regulatory compliance, maintaining manufacturing data, and contributing to continuous improvement initiatives within a regulated environment.
• Candidates should have at least 1 year of experience in medical device manufacturing, engineering testing, or related functions, with knowledge of compliance documentation, manufacturing processes, and basic programming skills.
• Strong analytical, problem-solving, communication, and documentation abilities are essential. A Bachelor's or Master's degree in Engineering (Electrical, Mechanical, Mechatronics, or related field) is required.
• Experience with Lean Manufacturing, process improvement, and test industrialization is preferred.
• The position is office-based and requires close collaboration within a manufacturing environment.