Medical device Test Engineer

Katalyst CRO; Pittsburgh (Allegheny County); On-site; USD 70,000 - 90,000; Full time

Job summary

Katalyst CRO is seeking a Product Industrialization Test Engineer to support the transition of medical device products from design to manufacturing. This role emphasizes improving manufacturing efficiency through Lean Manufacturing principles and collaboration in a manufacturing environment.

Qualified candidates should have at least 1 year of experience in related fields and a Bachelor's or Master's degree in Engineering. Essential skills include strong analytical, problem-solving, communication, and documentation abilities.

Qualifications

• At least 1 year of experience in medical device manufacturing, engineering testing, or related functions.
• Knowledge of compliance documentation and manufacturing processes.
• Basic programming skills are preferred.

Responsibilities

• Support transition of medical device products from design to manufacturing.
• Improve manufacturing efficiency and implement Lean Manufacturing principles.
• Execute test protocols and ensure regulatory compliance.

Skills

Analytical skills

Problem-solving

Communication

Documentation

Lean Manufacturing

Education

Bachelor's or Master's 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.