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.
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.
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.
Relevant experience (pharmaceutical industry, combination products, medical devices, etc.)
Data analysis (software: e.g., JMP, Minitab)
Project management / multi-tasker to enable managing multiple deliverables/priorities.
Design Controls / Combination Products.
Problem Solving / Root Cause Analysis
Strong individual contributor
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
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.
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 email@example.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.