Description

You will lead test method development and validation for the Lung Health ILLUMISITE system to meet regulatory requirements.

This role is on-site.

Responsibilities

• Own test method development and validation for products within the ILLUMISITE system.
• Conduct gap assessments of existing test methods against current regulatory requirements.
• Characterize test methods to ensure they meet Gage R&R maximum thresholds.
• Collaborate with Design Quality Engineering to align on testing methodologies.
• Develop, execute, and document test protocols and analytical results.

Required Skills

• Bachelor's degree in Mechanical Engineering.
• 5+ years of relevant mechanical design experience.
• Proficiency in SolidWorks.
• Demonstrated experience with Gage R&R analysis.
• Proven expertise in test method development.
• Knowledge of basic statistical analysis.
• Ability to provide technical support for regulatory body submissions.

Preferred Skills

• Experience with Gage R&R analysis in a regulated medical device environment.

Key Skills

Education

Any Graduate