Mechanical Engineer, Instruments - Future Opportunity

Job description

Essential Job Duties 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 change control procedures 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 Performs other duties as required to support the company's overall strategy and goals Required Skills and Experience 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, adhesive/thermal/mechanical joining, electromechanical integration etc.) Proficiency in CAD-based mechanical design (SolidWorks preferred) Experience working with suppliers Ability to work independently under limited supervision while knowing when to escalate Strong analytical and problem-solving skills Effective written and verbal communication Required Education and Training Minimum education: BS or MS in Mechanical Engineering, Mechatronics, Biomedical Engineering or related engineering or scientific discipline, or equivalent work experience Preferred Skills and Experience Experience with flexible electromechanical device development is a strong plus Experience with energy delivery devices is a plus Working Conditions Must be available to work full-time and commute/relocate to Sunnyvale, CA Up to 10% travel. Some international travel may be required. Primary Location: Sunnyvale, CA