Staff Mechanical Engineer/Project Manager
Hansen Medical - Mountain View, CA

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Summary:

The successful applicant will work in a technical leadership role and lead product development teams through all phases of new product development including ideation, clinical applications, concept development, detailed engineering and testing, DFM and transfer to operations. The job involves significant individual contribution at the technical level but the candidate must have the ability to lead a team of 3-5 engineers. This candidate will be responsible for ensuring the output from this team results in an integrated product that meets performance, schedule and cost requirements. This technical team leader will be expected to challenge all technical aspects of the project and insist on deeper technical rigor and increased optimization/understanding where appropriate but also know when to freeze the design and execute on design control deliverables. The position will offer unique and complex engineering challenges that require persistence, original thinking and a positive attitude. Therefore, the candidate must have a proven track record of innovation, making sound technical decisions and getting technically complex, integrated products to market with aggressive timelines.

Essential Functions:

  • Mechanical Design of the interface between next generation catheters and robots.
  • Provide technical leadership to development teams in mechanical, electromechanical and controls design.
  • Choose new technologies and materials and identify and interact with strategic vendors to obtain engineering materials, processes, and equipment
  • Interface with marketing and clinical to ensure customer requirements are understood and transferred correctly to engineering specifications.
  • Work with cross functional teams to identify, plan and execute tasks to bring products from concept through to market release.
  • Provide technical guidance to teams to develop and improve manufacturing processes to pilot production level
  • Assist in debugging and optimizing system performance, on bench and in vivo studies
  • Assist in the preparation and review of patent applications

Requirements:

  • 6 years, minimum, experience as a development engineer in the medical device industry
  • Minimum of 2 years in technical lead role integrating the work of multiple project engineers
  • Bachelor’s degree in Mechanical Engineering, Master’s degree preferred
  • Extensive knowledge and proven track record of complex mechanical designs
  • Expert knowledge of engineering materials for machining and injection molding
  • Fully proficient in Solidworks
  • Experience with rapid prototyping
  • Must have a demonstrated ability to effectively and clearly communicate technical concepts, ideas and knowledge to other individuals and teams
  • Strong analytical and problem solving skills, as well as a good background in the product development process
  • Experience working with ISO requirements, GMP guidelines, FDA regulations, medical device design control, and manufacturing scale-up processes
  • Previous small-company experience a plus
  • Strong creative and innovative ability

Hansen Medical, Inc. is an Equal Opportunity Employer.


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