Medical Device R&D Engineer — Test Methods & Analytics

Infotree Global Solutions; Cambridge (MA); Vor Ort; USD 65.000 - 95.000; Vollzeit

Zusammenfassung

Infotree Global Solutions in Cambridge, MA is seeking a candidate with 3+ years of experience in a regulated environment to support the Physical Sciences and Engineering initiatives. The role emphasizes development and lifecycle management of physical GMP test methods, validation of test systems, and translating user needs into engineering documentation.

The ideal candidate has a math/statistics background, exposure to CAD/SolidWorks, and hands-on lab experience.

Qualifikationen

• 3+ years of experience in a regulated field; bachelor's degree required.
• Experience with GMPs and medical device environment preferred.
• Strong fundamentals in statistics and data analysis.

Aufgaben

• Develop and manage physical GMP test methods and associated documentation (test method protocols, SOPs, training documents).
• Validate and lifecycle-manage testing equipment and systems.
• Assist with engineering studies for automated test systems installations.
• Analyze test data and report findings to stakeholders.

Kenntnisse

Regulated industry

GMP exposure

Statistics fundamentals

Test method development

CAD design

SolidWorks

Mechanical modeling

R

Python

Lab experience

Ausbildung

Bachelor's degree in Engineering or related field

Tools

SolidWorks

Gage R&R

Jobbeschreibung

Infotree Global Solutions in Cambridge, MA is seeking a candidate with 3+ years of experience in a regulated environment to support the Physical Sciences and Engineering initiatives. The role emphasizes development and lifecycle management of physical GMP test methods, validation of test systems, and translating user needs into engineering documentation.

The ideal candidate has a math/statistics background, exposure to CAD/SolidWorks, and hands-on lab experience.