Overview
The primary purpose of this position is to lead projects to design, test and technically document design and/or process changes required for the maintenance of released medical devices. Specific project work typically involves changes initiated by our suppliers and/or requested by procurement.
Responsibilities
Serve as technical and project leader for product modifications resulting from supplier initiated changes and internal requests from procurement.- Evaluate and address component related quality issues with operations and the impacted supplier.- Work with suppliers to create or modify raw material specifications- Lead complex projects independently, or with minimal supervision- Independently interface with quality engineering, production engineering and operations personnel to coordinate design and process changes- Prototype devices and develop test fixtures to evaluate design and/or process changes- Consult with physicians and healthcare professionals to discuss validation test set-ups or to evaluate design changes
Must work and interact effectively and professionally with and for othersthroughout various levels of the global organization- Excellent problem solving skills and ability to work in collaborative andindependent 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 attendCompany exhibitions.- Ability to remain calm and receptive in fast paced situations
Qualifications
PhD in Engineering or Engineering Technology; or- MS in same with 1 year relevant experience; or- BS degree in same with 3 years relevant experience- Knowledge of medical device quality and regulatory systems
Ability to work independently and remain self-motivated.- Displays ability to use problem solving skills to reason through challenges.- Excellent written and verbal communication skills.
Physical Requirements:
Must be able to perform the essential functions of the job, with or without reasonable accommodations.
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. No more than 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.
Requisition ID2024-13696
Posting Date9 hours ago(1/24/2024 4:11 PM)
Job Location(s) Winston-Salem NC United States
Position Type Full Time
Company Cook Winston-Salem
Category Engineering