The Sustaining Engineer at Cook Vandergrift will lead product and process remediation efforts, in addition to performing sustaining activities for commercially available products.
- Interface with 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 timeliness, resources and responsibilities to achieve team, departmental, and company goals.
- Follow Risk Management procedures and comply with requirements of ISO 14971 as applicable.
- Follow Design Control and risk management procedures and comply with requirements of 21CFR820 Quality System Regulations and ISO 13485 as applicable.
- May supervise / coach technicians or other engineering employees.
- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
- Must work and interact effectively with others throughout various levels of the organization
- Must strictly adhere to safety requirements
-Must maintain regular and punctual attendance
-Must maintain comply quality and quantity standards
- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision
• Bachelors Degree in Biomedical or Mechanical Engineering or equivalent
• 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