Biomedical Quality Engineer I (Inspection/Keyence)

About the Role

• Support supplier and receiving inspection activities for qualifying components in support of development, transfer, and launch of new Aortic transcatheter valve replacement delivery system devices.
• Seeking a strong, highly collaborative engineer with solid technical expertise in a fast-paced and rapidly growing environment.
• The ideal candidate is a self-starter with excellent communication skills and demonstrated skills in data analysis and problem-solving.

Key Responsibilities

• Development of component inspection methods and plans, test method validation, component capability assessment, and validation of supplier processes.
• Interpret engineering drawings, schematic diagrams, or formulas and confer with management or engineering staff to determine quality and reliability standards.
• Support drawing reviews to ensure inspection DFX considerations are incorporated into designs.
• Complete component qualification documentation and approval routing.
• Support receiving inspection and component inspections for milestone builds.
• Manage investigation and risk-based escalation of non-conformance issues.
• Support transfer of receiving inspection processes to other EW or supplier sites.

Requirements & Tech Stack

• Creativity, verbal and written communication skills, analytical and problem-solving ability.
• Team player and detail-oriented.
• Ability to read and interpret technical drawings, schematics, and computer-generated reports.
• Previous experience with computer applications and software related to the engineering field, such as Computer-Aided Design (CAD).
• Specific experience in component qualification, inspection methods and fixture development, test methods and process validation, statistical methods, and ability to work with cross-functional partners is preferred.

Qualifications

• Bachelor's degree in engineering required.
• 0-2 years of experience required.