Medical Device Test Method Engineer

Infotree Global Solutions

Cambridge (MA)

On-site

USD 90,000 - 130,000

Full time

25 hours ago
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Job summary

Infotree Global Solutions is seeking a candidate with 3+ years in the field and a bachelor's degree to support the design and deployment of physical GMP test methods for the Combination Product Operations MS&T - Physical Sciences and Engineering.

Responsibilities include development and lifecycle management of test methods and integrated testing equipment, with emphasis on user requirements and technical documentation.

Qualifications

  • Experience in a regulated industry with GMP exposure.
  • Bachelor's degree in a relevant field.
  • Strong background in statistics and data analysis.
  • Familiarity with test method development, CAD design, and modeling.
  • Experience with medical device projects and lab work.

Responsibilities

  • Support initiation, design and delivery of projects within PSE.
  • Develop and lifecycle manage Physical GMP Test Methods.
  • Lifecycle management of automated test systems and equipment.
  • Develop, validate and document test methods and protocols.
  • Perform engineering studies for automated test system installations.
  • Analyze data from test protocols and prepare technical docs.

Skills

GMP experience
Medical device experience
Statistics
Test method development
CAD design
SolidWorks
Mechanical modeling
R
Python
Lab experience
Data analysis

Education

Bachelor's degree

Tools

SolidWorks
Python
R

Job description

Infotree Global Solutions is seeking a candidate with 3+ years in the field and a bachelor's degree to support the design and deployment of physical GMP test methods for the Combination Product Operations MS&T - Physical Sciences and Engineering.

Responsibilities include development and lifecycle management of test methods and integrated testing equipment, with emphasis on user requirements and technical documentation.

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