Position Summary/ Department Summary:
Provides engineering services to clinical and research areas throughout the Boston Children's Hospital organization related to: medical device technology planning, implementation, and operationalization; complex medical device/system trouble-shooting and management; medical device regulatory oversight; and clinical engineering project management. Serves as a Resource Engineer for higher-level medical devices, systems, and/or care areas.
Embodies the Hospital's core values in all interactions with patients, families, and colleagues.
Key Responsibilities:
- Independently manages medical device projects, including assessing and planning for clinical/technical needs, facilitating device selection, planning infrastructure and other needs associated with a project, managing installation, and coordinating clinical/technical training and operational hand-off.
- Independently works with multi-disciplinary teams on project phases listed above and may lead a team consisting of BMETs and/or other engineers.
- Evaluates and responds to medical device manufacturer and FDA hazard alerts and recalls.
- Tracks medical device regulatory compliance, including input on policies and procedures.
- Works with research departments to assess and approve research devices to be used in the hospital.
- Works with department leadership, technical staff, and other hospital departments on clinical incidents related to medical devices.
- Assists in capital project budgeting and purchasing, including operational impacts.
- Serves as a Resource Engineer for higher-level medical devices, systems, and/or care areas. Resource Engineer responsibilities include working with clinicians, mentoring/training technical staff, and working with manufacturers and/or vendors to ensure proper management of the device/system.
- Produces and maintains internal documentation of medical device systems for technical reference.
- Maintains knowledge of current regulatory codes and standards related to the department.
Minimum Qualifications
Education:
Bachelor's degree is required; area of study required: Biomedical Engineering, Clinical Engineering, Electrical Engineering or related field.
Clinical Engineering, Biomedical Engineering is preferred.
Experience:
3 plus years of experience in Health Technology Management (Biomedical/Clinical Engineering) in industry or academic setting or equivalent setting.
Experience in Health Technology Management (Biomedical/Clinical Engineering) in a hospital preferred.