Project Manager/Manager/Technical Lead

Senior R&D Catheter Engineer/Project Manager

Summary:

The Sr. Catheter Engineer will work in a project leadership role and lead product development teams through all phases of new catheter product development including ideation, clinical applications, concept development, V&V and transfer to manufacturing. The senior engineer will be responsible for project schedules and will be expected to take a 'hands-on' approach to the job to ensure projects stay on track. The role may also involve leading the cross functional core team but this will depend on the experience of the applicant.

Essential Functions:

* Lead design and develop teams for next generation steerable catheters.
* Prepare project plans, specifications, and schedules for new product development.
* Drive consensus among core team members to finalize project scope.
* Provide leadership and guidance through verification and validation phases of new product designs.
* Prepare and manage test protocols, testing and reports.
* Identify and interact with vendors to obtain engineering materials, processes, and equipment.
* Perform routine analysis of test results in relation to design specifications and test objectives.
* Assist in debugging and optimizing system performance and contribute to regulatory submissions.
* Assist in the preparation and review of patent applications.

Requirements:

* 5 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 Engineering or Science, Master's degree preferred.
* Extensive knowledge and proven track record of catheter design, (preferably with steerable catheters) manufacturing process skills and rapid product development.
* 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.
* Hands-on prototyping skills
* Proficient in Solidworks
* 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 ability.
* Trained in Design for Six Sigma practices, statistical data analysis, DOEs, Gage R&Rs, a plus.
* Experienced at presenting technical data to senior management to help with decision making.To find out more about Real Staffing please visit www.realstaffing.com