Description

You will lead quality engineering and risk management for new surgical product development.

This role is on-site.

Responsibilities

• Lead and develop Design Failure Modes and Effects Analysis (DFMEA) and Critical to Function matrices.
• Manage risk management processes in accordance with ISO 14971.
• Develop, review, and approve Design Verification and Design Validation protocols and reports.
• Establish reliability test methods, conduct reliability studies, and perform statistical analysis.
• Drive product quality and continuous improvement across cross-functional teams.

Required Skills

• Bachelor's degree in Engineering, Science, or a Technical field with 4+ years of experience (or Advanced degree with 2+ years).
• Hands-on experience conducting DFMEA and Critical to Quality (CTQ) analysis.
• Proficiency in defining Critical to Quality (CTQ) and Critical to Function parameters from design, part, component, and assembly perspectives.
• Experience with reliability test method development and strategy.
• Strong understanding of mechanical and electro-mechanical design principles.
• Knowledge of Electromagnetic Compatibility (EMC) requirements, testing, and development.
• Competency in monitoring CTQ parameters and specifications.

Key Skills

Education

Bachelor's degree