The Sustaining Engineer at Cook Inc. will lead product and process remediation efforts, in addition to performing sustaining activities for commercially available products.
• Interface with Contract Engineers, Development Engineering, Production Engineering, Product Management, Regulatory, Clinical, Quality Engineering, Quality Assurance, Operations, sourced vendors and physicians as necessary to progress projects/tasks
• Manage multiple project timelines, resources and responsibilities to achieve team, departmental, and company goals
• Analyze risk using CEA and current FMEAs
• Follow Design Control procedures and comply with requirements of 21CFR820 Quality System Regulations, ISO 13485 and ISO 14971 as applicable
• Identify user needs and develop into design input requirements
• Formulate Verification & Validation Test Plan and collaborating with other COOK departments to execute testing
• Update device and production specifications accordingly
• May supervise / coach technicians or other engineering employees
- Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
- Must strictly adhere to safety requirements.
- Maintain regular and punctual attendance.
- Must maintain company quality and quantity standards.
- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with
- Ability to remain calm and receptive in fast paced situations.
- Bachelors Degree in Biomedical or Mechanical Engineering
- Previous project management experience preferred.
- Knowledge of statistical practices as it relates to sample sizes, confidence intervals, capability, assessing risk and problem solving.
- Proficient in Microsoft Word/Excel/Outlook.
- Works under general office environment conditions.
- Utilizes close visual acuity for working with computers and equipment.
- Frequently required to sit, stand, walk, and communicate.
- Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA
**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.**