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