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Mechanical Engineer II
Mechanical Engineer IIArevna • Houston, TX, US
Mechanical Engineer II

Mechanical Engineer II

Arevna • Houston, TX, US
8 days ago
Job type
  • Full-time
Job description

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

  • Proficiency in CAD and simulation tools (SolidWorks preferred).
  • Experience designing electro-mechanical systems.
  • Strong knowledge of FEA, GD&T, and tolerance stack-up.
  • Expertise in DFM (injection molding, machining).
  • Root cause analysis and solution implementation in fast-paced environments.
  • Ability to conduct and interpret engineering studies.
  • Experience writing and reviewing V&V protocols and reports.
  • Strong communication skills for cross-functional collaboration.
  • Hands-on prototyping, assembly, and troubleshooting experience.

    • Preferred Skills

  • Experience with medical robotics or complex instrumentation.
  • Background in flexible endoscope or similar device manufacturing.
  • Knowledge of biocompatible materials (ISO 10993) and sterilization (ISO 11135).
  • Familiarity with medical device standards (ISO, ASTM, IEC 60601).
  • Ability to review patents / IP.
  • Experience with DFMEA or risk management.
  • Rapid prototyping (3D printing, soft tooling).

    • Education & Experience

  • Bachelor's or advanced degree in Mechanical Engineering, Industrial Engineering, or related field.
  • 3+ years of engineering experience in medical device, robotics, or precision engineering (strongly preferred).
  • Familiarity with regulatory requirements (FDA, ISO).

    • Physical & Travel Requirements

  • Desk / computer work and occasional standing.
  • Ability to lift / carry 25 lbs.
  • Up to 20% travel preferred.
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