Responsibilities:

· Develop complex designs and manufacturing processes for products that are reliable, high yield, cost effective, consistent, and require minimal training and supervision to manufacture.

· Develop project schedules, determine resource requirements, and lead cross-functional project teams.

· Adhere to Product Development Procedure.

· Develop and perform testing, test methods and apparatus for evaluating the safety and reliability of products.

· Create DMR's, write manufacturing instructions, create drawings, write protocols for verification and validation testing, write test reports, maintain a laboratory notebook.

· Will require extensive interaction with marketing and other R&D engineers to characterize and understand the user and clinical needs for new products

· Develop and maintain Design History Record.

· Work with technicians to design and develop new products.

· Work with Pilot Manufacturing to train assembly operators in the manufacture of products.

· Work with Manufacturing and Process Engineering to qualify and validate products for manufacturing.

Qualifications:

· Must have a B.S. degree in Engineering and/or related science

· Minimum of 6 years experience in the development of mechanical designs with at least 3 years of medical device experience.

· Demonstrated experience leading product development efforts and experience in some of the following areas: RF-based or energy applying medical device design, catheter design, advanced machining processes, selection and validation of patient contacting materials.

· Experience with 3-D modeling software (Pro-E or Solidworks) is required along with a thorough understanding of FDA and MDD design control requirements for medical devices.

· The successful candidate must have excellent communication skills and be able to work with people at all levels of organization.

· Candidate must be able to travel to observe clinical cases, visit suppliers, and work with OUS manufacturing sites

· Must be able to travel at least 25% (domestic and international)