Mechanical Engineer II (Houston)

About the Company

A cutting-edge medical technology organisation. Partnering with leading healthcare providers and clinicians, this company is redefining surgical capabilities through advanced instrumentation, precision engineering, and high-performance visualisation technologies. The culture is collaborative, high-performing, and innovation-led.

Role Overview

The Mechanical Engineer II will play a key role in the design, development, and manufacturing of complex medical device components. This role is hands-on and highly cross-functional, ensuring design concepts are translated into scalable, compliant, and manufacturable products.

Key Responsibilities

• Design and develop fixtures, jigs, and tooling for assembly, calibration, testing, and manufacturing scale-up.
• Support production line setup and troubleshoot mechanical issues during ramp-up and sustaining phases.
• Develop V&V test protocols, reports, fixtures, and equipment.
• Design mechanical components and assemblies from concept to production release.
• Ensure compliance with Good Documentation Practices (GDP) across design reviews, drawings, specifications, and BOM.
• Collaborate with Quality on CAPAs, NCRs, and root cause investigations.
• Incorporate clinical and marketing feedback into design outputs aligned with customer and regulatory requirements.
• Support regulatory submissions, product launch, and transition to manufacturing.
• Hands-on fabrication, assembly, and troubleshooting of prototypes.
• Participate in design reviews and lead continuous improvement for manufacturability and compliance.
• Build and maintain effective relationships with vendors and suppliers.

Required Skills & Experience

Preferred Skills

Education & Experience

Physical & Travel Requirements