Senior Mechanical Engineer, Instruments

Job description

Job responsibilities

• Work in a small, cross-functional project team to design, develop and verify new concepts for advanced energy catheters and/or flexible electromechanical instruments and related accessories (e.g. medical cables)
• Develop, implement, test and document new solutions, processes, and designs according to corporate standards and departmental operating procedures
• Hands-on assembly and testing of devices to support proof of concept, design development, pre-clinical and V&V activities
• Investigate and determine root cause of emerging design or manufacturing defects/failures.
• Development and documentation of design and manufacturing documentation including inspection procedures, assembly instructions, test methods, purchase specifications, BOMs, part and assembly drawings using appropriate…
• Collaborate with clinical engineering team to assess product concepts and do tradeoff analysis of proposed designs and feature sets
• Observe clinical cases and participate in interviews with clinical experts to inform designs; provide support for pre-clinical labs and clinical cases
• Establish individual goals consistent with overall project goals

Job requirements

• Typical minimum of 8 years of relevant experience, minimum 6 years with a masters
• Demonstrated ability to work in cross-functional research and development teams
• Experience with FDA QSR 21 CFR Part 820, ISO 13485, ISO 14971 and other related standards desired
• Proven track record operating in highly ambiguous environments with limited data, effectively identifying key risks and prioritizing experiments to accelerate learning
• Hands-on experience with rapid prototyping methods for flexible instruments and associated components, including 3D printing, plastics processing, metal fabrication, and bench-level assembly
• Proficiency in CAD-based mechanical design (SolidWorks preferred)
• Experience with part/mechanism design including 3D printing and plastic injection molding
• Experience in integrating fluid management features within flexible instruments (irrigation, perfusion, cooling, etc.) preferred.