Mechanical Engineer II
hace 1 día
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 • 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.