Biomedical Engineer
Aerotek’s client is hiring for Biomedical Engineers in the Maryland area. I would like discuss your background and long term goals in order to see what your current situation looks like and what type of opportunities you would be interested in now or in the future.
Biomedical Engineer- Lab Team
- Will prepare documents, develop & make usability samples, test samples, assist in formative study execution, QC data & reports. Assist in the summative study execution and updating QC data & reports.
- Analyze, photograph & research product. Develop protocols & test fixtures, test product & reports. Create presentations & market landscape analysis. Update market landscape analysis & document technical assessment process.
- Analyze patents, applications & research product information. QC & develop reports. Create presentations. Update Intellectual Property analysis & document technical assessment process.
- Perform gap analyses; develop design options, prototype & test solutions, QC & report.
- Perform gap analyses; develop design options, prototype & test solutions QC, report & documentation.
- Research technical feasibility; develop design options, SWOT analyses, prototype & test solutions QC & report and documentation.
Qualifications
Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or similar applied science with a 3.5 or higher GPA. Some knowledge of drug/device combination products.
Biomedical Engineer- Design History File Team
- Reviewing hundreds of historical documents in hard copy and electronic formats to retrospectively construct the design and development history of multiple drug/device combination products in accordance with company document control Standard Operating Procedures (SOPs) and Food and Drug Administration (FDA) regulations.
- Conducting gap analyses and support efforts to fill identified gaps.
- Researching how the products design influences the way people interface with the product (EPI pen)
- Understanding how to read blueprints and schematics
- Reviewing 60 years of historic documents and formatting the design history files for the FDA, technical writing skills are important
- Utilizing lab equipment and perform research and data collection on the results of their studies
- Understanding and applying design control regulations FDA 21 CFR 820.30 & FDA 21 CFR Part 4.
- Testing the drug delivery methods and running some clinical trials to see how user friendly the device is.
Qualifications
Bachelor’s degree in Biomedical Engineering, Bioengineering, or Mechanical Engineering with a minimum of 3.5 or higher GPA.
Please send resumes to ftsegai@aerotek.com .
Feven Tsegai
Senior Recruiter Lead
ftsegai@aerotek.com
410-567-8002