PLEASE email your resume to snipped-for-privacy@intusurg.com
Sunnyvale, CA
Roles and Responsibilities: This position has responsibility and authority for:
=95Design and document components and assemblies for surgical systems, particularly instruments =95Assess field reliability data and improve existing product designs as determined by customer data =95Investigate clinical requirements, partners with clinical engineering/ product marketing teams =95Create product functional and design specifications =95Create product architectures =95Analyze and test product designs =95Develop and perform component verification testing and product validation testing =95Leads Project teams mentoring interns and contractors, facilitates vendor participation and cross functional communication in order to meet project deadlines/goals =95Develop vendors to manufacture components =95Develop initial fixtures and processes to assemble components =95Develop product assembly instructions =95Support production of final product by troubleshooting process and component problems =95Provide engineering support to Manufacturing, Materials, Test Engineering, and Service to facilitate transfer of designs. =95Develop Design History Files per FDA requirements =95Act as technical mentor to Mechanical Engineers =95Serve as Mechanical / Design Engineering member of Design Review Boards =95Document, prepare and review patent and regulatory submissions
ADDITIONAL REQUIREMENTS =95Competency Requirements: (Competency is based on: education, training, skills and experience.) In order to adequately perform the responsibilities of this position the individual must: =95BSME required, MSME preferred =95Minimum 8 years experience designing commercial mechanical products; strength in design analysis =95Proficiency using CAD to design and document mechanisms; ProE and/or SolidWorks preferred =95Hands-on engineering with the proven ability to work well in a team environment Comfortable with all phases of the product development lifecycle including design, implementation, debug, verification, qualification, and transfer =95Good communication and project/program team leadership skills; influencing across organizations =95Comfortable operating machine shop, measurement and test equipment =95Strong understanding of component selection criteria, and design for reliability and manufacturability =95Prefer medical product design and development experience =95General regulatory knowledge required for documentation with strong written communication skills Proficient at process development and creation of assembly instructions