Biomedical Engineer - Urgent Hire

Role : Biomedical Engineer

Location: Bethesda, MD

Type : Fulltime

What you'll do:

Provide training to new and inexperienced personnel on new software and upgrades of existing software

Consult and design medical devices using CAD software packages for additive manufacturing

Prepares briefs and technical manuals as requested by supervisors.

Ensure all projects are documented for review.

Participate in the development of a wide variety of special models, experimental implants, special models related to medical simulation, dental and related medical research

Coordinate the construction of experimental or prototype medical devices, fixtures, simulators and attachments.

Coordinate the manufacturer of components for experimental, development and production programs.

Model human tissue in both macro and micro scale using scan types (CT, MRI, PET), laser surface scans, and visual light 3D imagery.

Teach and create SOPs for the manufacturing processes and model construction of simulation models

Provide training to personnel on equipment handling, while ensuring safety practices on biohazard disposals.

Participate in new/orienting research projects in multiple areas of medical modelling such as implant design, stress analysis simulation and animations.

Develop or assist in the development of new simulators and task trainers for provider education.

Maintain and monitor quality management system (QMS) documentation and processes for additively manufactured medical devices per 21 CFR 820 and ISO 13485.

Participate in the product development process for 3D printed medical devices for future 510(k) submission.

Participate in risk assessments for software and medical device products per ISO 14971.

Drafts protocols and executes software, machine, and design verification and validation (V&V) activities.

Qualification:

Minimum 5 years' experience with 3D medical modelling and additive manufacturing of medical devices and advanced working knowledge of MIMICS, MAGICS, and FREEFORM software or other medically relevant CAD software programs used in patient care.

Knowledge of human anatomy, physiology and computerized imaging

Capability to learn diagnostic radiology and radiographic interpretations, as it is used in preparation of 3D models.

Knowledge of common manufacturing procedures, including silicone moulding, sculpting, construction and finishing of simulation models or medical devices. Ability to teach manufacturing processes and construction to other facilities.