Biomedical Engineer

Biomedical Engineer

Job Description

Integrated Management Strategies, a professional consulting firm, seeks a Technical Writer to provide full-time in support of the Quality Control and Regulatory and Simulation and Dental sectors of the 3D Medical Applications Center Department of Radiology of a four-year contract in Bethesda, MD. The ideal candidate may have experience working in a dental laboratory as a dental technician. We are especially interested in candidates with FDA Regulatory Compliance and or Medical Simulation experience and excellent verbal, written communication, and organizational skills.

Location  Onsite, Bethesda MD 

Req Type Full-Time/Permanent

Travel  No

Summary

The Technical Writer II will support the Quality Control and Regulatory and Simulation and Dental sectors of the 3D Medical Applications Center Department of Radiology to support a US Government Agency. Technical Writer II will follow directives and complete assignments from the Director of Services and Biomedical Engineer of the 3D MAC. The Technical writer may also apply writing skills and an understanding of the appropriate equipment and systems to the development of specifications showing the characteristics and capabilities or the design and test requirements of equipment and systems; or to the development of training, operating, or maintenance manuals associated with equipment and systems.

Primary Responsibilities

• Participate or assist in the development and formulation of quality systems documents focused on additively manufactured parts and devices, processes controls, verification and validation, and 510k submissions in accordance to FDA regulations or ISO 13485 standards.
• Work as a liaison between 3D MAC and several other hospital departments including, but not limited to, Hospital Dentistry, Naval Post Graduate Dental School, and the Department of Simulation.
• Collaborate with medical device designers using CAD software packages for additive manufacturing.
• Run risk assessments and support quality control and assurance system implementation.
• Prepares briefs and technical manuals.
• Ensure all projects are documented for review.
• Participate in the development of experimental implants, special models related to medical simulation, dental and related medical research for government review and approval.
• Coordinate the construction of experimental or prototype medical devices, fixtures, simulators, and attachments.
• 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 for military treatment facilities.
• Train personnel on equipment handling, while ensuring safety practices on biohazard disposals.
• Participate in new/orienting research projects in multiple areas of medical modeling such as implant design, stress analysis simulation and animations.
• Investigate future application of additive manufacturing in dentistry and help to determine the feasibility of 3D MAC expanding their service to offer new items and devices. 

Required Skills

• Minimum 5 years’ experience with 3D medical modeling 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 is required.
• Capability to learn diagnostic radiology and radiographic interpretations, as it is used in preparation of 3D models.
• Knowledge of common manufacturing procedures, including silicone molding, sculpting, construction and finishing of simulation models or medical devices.  Ability to teach manufacturing processes and construction to other facilities.
• Experience in technical writing, with excellent written and verbal communication skills; skillful in analytical and logical capabilities; detail oriented; ability to work independently; strong editing skills; highly competent in Microsoft.
• FDA Regulatory Compliance
• ISO 13485

Education

Bachelor’s degree is required with Major coursework in Journalism or English, or a related field; courses in basic Sciences is required. Work experience may be adjusted for highly specialized knowledge or uniquely applicable experience.

Qualifications

Job Type:                 Full-time, 40 hours per week
FLSA:                        Exempt
Work Schedule:    Monday – Friday
Shift :                      First
Location:               Onsite in Bethesda, Maryland
Salary :                  $Negotiable/year
Relocation:            No

Email resumes to: resumes@im-strat.com

IMS is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, gender identity, national origin, disability, pregnancy, status as a protected veteran, or any other protected characteristic as outlined by federal, state, or local laws. If you are an individual with a disability and would like to request a reasonable accommodation for the employment process, please email your request to hr@im-strat.com.

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