Biomedical Engineer

Integrated Resources, Inc ( IRI ); Boston (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading biomedical solutions company located in the Boston area is seeking a qualified individual to develop test plans for clinical trials, ensuring compliance with regulations and standards. The successful candidate will have a degree in Biomedical Engineering and experience in testing methods, document work accurately, and work effectively in a cross-functional team environment. Applicants should possess strong technical writing and communication skills, along with knowledge of laboratory equipment and regulations.

Qualifications

• 3-5 years of experience for B.S., 1-3 for M.S., or up to 1 year for Ph.D.
• Experience in combination of chemistry and biology preferred.

Responsibilities

• Develop test plans for clinical trials.
• Devise client testing approaches as needed.
• Document work following Good Documentation Practices.
• Establish experimental protocols and analyze results.

Skills

Ability to run ultra-high performance liquid chromatography system

Effective technical writing

Effective verbal communication

Working knowledge of 3D CAD software (SolidWorks)

Familiarity with safe laboratory operations

Education

B.S. in Biomedical Engineering or related fields

Tools

Ultra-high performance liquid chromatography system

Optical measuring systems

Job description

Responsibilities

• Develop test plans for prototypes and products under development for clinical trials with respect to regulations, standards, and company quality systems.
• Devise Client testing approaches when existing methods and/or equipment are not appropriate by sourcing or creating new test equipment.
• Use first principles, statistics, and Six Sigma concepts to develop robust test methods and analyze data.
• Document work clearly, accurately, and with high quality following GDP.
• Manage work as part of the overall team.
• Establish experimental protocols, conduct experiments, analyze results, document the information, and present conclusions/recommendations to cross functional team.
• Working knowledge of setting and operation of pulmonary and nasal device testing equipment, e.g. spray particle size analyzer, Copley Scientific Breathing Simulator, Next Generation Product Impactor.
• Working knowledge of safe operations to interact with powder/nebulized particles/droplets.
• Working knowledge of Good Documentation Practices.

Qualifications

• B.S. with 3-5 years of experience, M.S. with 1-3, Ph.D. with 0-1 years of experience in Biomedical Engineering or related fields (combination of chemistry and biology preferred).

Additional Skills/Preferences

• Ability to run equipment such as an ultra-high performance liquid chromatography system and optical measuring systems.
• Familiarity with purchasing and procurement of supplies and materials for prototyping and testing.
• Effective technical writing, verbal communication, and presentation skills.
• Working knowledge of 3D CAD software, preferably SolidWorks.
• Ability to wear respiratory protective equipment, as needed, to safely work in lab.
• Experience with appropriate regulations (CRF 820.30, ISO 13485, ISO 14971, etc.).