The primary purpose of this position is to design, test and technically document design changes required for the maintenance of released medical devices.

- Serve as technical and project leader for product modifications involving design and/or process improvements - Consult with physicians and healthcare professionals to discuss validation test set-ups or to evaluate design changes- Provide support to regulatory department for product registrations with FDA and other global notified bodies- Develop and maintain Design History Files- Interface with production engineering and operations personnel to coordinate design and process changes- Work with suppliers to create or modify raw material specifications- Prototype devices and test fixtures to evaluate design and process changes- Interact with the machine shop personnel to develop tooling and equipment for use in production

- Must work and interact effectively and professionally with and for others throughout various levels of the global organization- Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision - Must strictly adhere to safety requirements- Maintain regular and punctual attendance- Must maintain company quality and quantity standards- Must have effective oral and written communication skills- Attend various trade shows to source raw materials or to attend Company exhibitions.

- Bachelor's degree in Engineering or Engineering Technology or related discipline and minimum 3 years of prior relevant experience. Advanced degrees may reduce the experience requirement by 1-2 years.- Ability to work independently and remain self-motivated.- Proven problem solving skills.- Ability to travel up to 10% of the time.- Excellent written and verbal communication skills.

Physical Requirements:

- Must be able to perform the essential functions of the job, with or without reasonable accommodations. - Limited exposure to hazardous chemicals used in the manufacture of the product.- Good Manual dexterity

- Approximately 90% of the time is spent in a normal office environment requiring sitting and moving around the building, or in a "clean" environment Production setting requiring protective clothing and safety glasses. Approximately 10% of the time is spent in travel to various suppliers, hospitals, and physicians’ offices.