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

• Bachelors 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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