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.
- 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 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
- Ability to remain calm and receptive in fast paced situations
- 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.
- 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.*