The Sustaining Engineer 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 timelines, 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 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 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.