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Engineer - Medical Device Combination Product (JP9593)

Cambridge, Massachusetts · Biotech/Pharmaceutical
Job Title: Engineer - Medical Device Combination Product (JP9593)
Location:  Cambridge, Massachusetts 02138
Employment Type: Contract
Business Unit: Development Product Engineering
Duration: 12 months with likely extensions
Job posting date: 1/10/2022
Note: Onsite Essential

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.

Job Summary:
  • This position reports into the Development Product Engineering Group in Cambridge, MA, supporting senior staff in the initiation, design, and delivery of combination product development projects.
  • This position requires the application of engineering principles to perform the job functions and the ability to coordinate and communicate effectively across different functions to successfully complete projects.

    This role will be required to:
  • Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation.
  • Assist with project definition by performing engineering studies/assessments for drug delivery systems for characterization or qualification in a GMP environment.
  • Author and execute protocols and technical reports summarizing key findings and results.
  • Perform field evaluations of existing systems and provide engineering design recommendations.
  • Design and develop combination product systems.
  • Provide detailed data analysis to and recommendations to enable senior staff to make informed decisions.

    Basic Qualifications:
  • B.S. in Engineering
  • Effective Communicator (Oral/Written)
  • Technical Writing (Protocols, Reports, Technical Assessments, Presentations)
  • Ability to be onsite in Cambridge, MA to support testing and development activities, willing to follow all Covid-19 safe working protocols and best practices.

    Preferred/Demonstrated Competencies
  • Relevant experience (pharmaceutical industry, combination products, medical devices, etc.)
  • Lab/testing experience.
  • Data analysis (software: e.g., JMP, Minitab)
  • Project management / multi-tasker to enable managing multiple deliverables/priorities.
  • Design Controls / Combination Products.
  • Regulatory Standards.
  • Problem Solving / Root Cause Analysis
  • Strong individual contributor
  • Team player
  • Fast and continuous learner
  • Flexible/highly adaptive to continuous changing priorities/environment

Top Must have Skill Sets:
  • BS in Engineering (Mechanical or Biomedical preferred)
  • Relevant experience (including co-op or internship) with combination products, medical devices 2-3 YOE
  • Proficient in MS Office Suite (Word, Excel) and statistical analysis (Minitab or JMP)
  • Testing experience nice to have

Day-To-Day Responsibilities:
  • Draft test protocols and reports
  • Hands-on testing in the lab
  • Statistical analysis of test results
  • Test method transfer and development
  • Gage R&R studies

Employee Value Proposition:
The person in this role will gain hands on experience in a lab doing testing. They will also gain experience working on drug delivery systems.

Red Flags:
  • Inability to be onsite as needed for testing.
  • Lack of ability to work independently.

Interview Process:
Phone screen then interview panel with approximately 3-4 staff members.
Available to start interviewing on Jan 4.


We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.

3KC Talent Acquisition Team
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