Arevna
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.
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.