Biomedical Engineer

Job Title
:
Biomedical Engineer

Location
:
Boston, MA

Work schedule
:
Mon
- Fri 8am- 5pm

Type
:
Contract

Global pharma company is seeking a highly motivated, skilled, and creative scientist or engineering professional to join our team to support the test and evaluation of formulations and prototypes.

• Develop test plans for prototypes and products under development for clinical trials with respect to regulations, standards, and company quality systems
• Devise novel 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 overall team
• Experience in establishing experimental protocols, conducting experiments, analyzing results, documenting the information and presenting 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 Cascade Impactor
• Working knowledge of safe operations to interact powder/nebulized particles/droplets
• Working knowledge of Good Documentation Practices
• B.S. with 3-5 years of experience, M.S. with 1-3, Ph.D. with 0-1 years of experience Biomedical Engineering or related fields (combination of chemistry and biology preferred)
• Attendance 5 days/week on-site for lab work

• Ability to run equipment such as an ultra-high performance liquid chromatography system and optical measuring systems
• Strong communication skills and the ability to be an inclusive colleague in a highly interdisciplinary environment
• Upkeep of a clean and healthy lab space
• Familiarity with purchasing and procurement with supplies and materials for prototyping and testing
• Effective technical writing, verbal communication, and presentation skills
• Working knowledge of 3D CAD software, preferably Solid Works
• 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.)

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.