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
? 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
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