Mechanical Engineer, Instruments - Future Opportunity

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, with guidance from senior engineers
• Perform hands-on assembly and testing of devices to support proof of concept, design development, pre-clinical and V&V activities; proactively communicating findings and flag issues to immediate team
• Support investigation 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 support 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 5 years of relevant experience with Bachelors, minimum 3 years with a Masters
• Demonstrated ability to work in cross-functional research and development teams
• Familiarity with FDA QSR 21 CFR Part 820, ISO 13485, ISO 14971
• Experience with rapid prototyping methods for instruments, components, and fixtures, including 3D printing and machining of plastics and metals
• Experience/exposure to flexible catheter design, including material selection and common fabrication methods to at least few of the following areas: polymer processing, reinforcement structures,…
• Proficiency in CAD-based mechanical design (SolidWorks preferred)
• Experience working with suppliers
• Ability to work independently under limited supervision while knowing when to escalate