Description

Owns verification and validation test plans, protocols, and fixture development for medical device projects.

Responsibilities

• Develop high-level verification and validation test plans for instrument, accessories, and vision projects.
• Generate and execute test protocols for Design Verification, Life/Reliability tests, and surgical simulations.
• Design test fixtures and test aids, documenting designs in SolidWorks and releasing them into Agile.
• Identify failure modes, perform root cause analysis, and escalate issues to engineering teams.
• Translate functional requirements into acceptance criteria and train technicians on test methods.

Required Skills

• BS in Mechanical, Biomedical Engineering, or similar degree.
• Minimum 2 years of work experience in an engineering organization or research team.
• Experience with MATLAB, Python, and Arduino.
• Proficiency with SolidWorks or similar CAD software.
• Ability to perform basic mechanical engineering calculations and dimensional analysis.
• Familiarity with electro-mechanical systems and standard test equipment (Force Gauge, Calipers, Oscilloscopes).
• Experience working with biological samples and understanding of Good Documentation Practices (GDP).

Preferred Skills

• Experience within the medical device or pharmaceutical industry.
• Agile methodology experience.

Key Skills

Education

Bachelor's degree