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.
**Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) of this employment position.**
“We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class.”Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.