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Test Engineer (Boston)

Mindlance, Boston, MA, United States


Job Title:

Test Engineer (Medical Device R&D)
Location : Boston, MA [Hybrid (4 days onsite)]
Schedule : Full-time, regular business hours
Duration : +9 months Contract with extensions & FTE conversion.

Job Summary
The

Test Engineer supports R&D for disposable medical devices

by developing and executing test strategies aligned with product requirements. This is a hands-on engineering role focused on test method development, data analysis, and validation activities within regulated environments.

Key Responsibilities


Develop, design, and execute test plans, protocols, and procedures to evaluate product performance against specifications
• Translate design requirements into testing solutions considering technical, cost, and schedule constraints
• Perform data analysis, document results, and recommend improvements to test methods, processes, or equipment
• Support prototype and product testing, including test fixture design and setup


Coordinate testing activities (lab space, equipment, vendors, timelines)
• Maintain R&D lab operations, including calibration records and preventive maintenance


Ensure compliance with FDA Quality System Regulations, ISO standards, and CE Marking requirements
• Apply statistical methods and experimental design principles where applicable
• Communicate findings via technical reports, presentations, and cross-functional collaboration
• Interface with engineering teams, suppliers, and stakeholders to support development goals

Required Qualifications
• Bachelor’s degree in engineering (Mechanical, Biomedical, Materials, or related field preferred)
• Minimum 2 years of engineering experience
• Strong hands-on execution and troubleshooting skills


Experience with SolidWorks or similar CAD tools
• Knowledge of product testing and validation processes

Preferred Qualifications


Experience

in

medical device development

under

FDA regulations
• Exposure to

statistical analysis

/

Design of Experiments

( DOE )


Experience working in a machine shop or machining environment

Technical Skills
• Lab equipment: microscopes, Instron testers, vibration
oise analyzers, etc.
• Tools: Microsoft Office (Excel, Word, PowerPoint), Minitab


CAD: SolidWorks, AutoCAD, eDrawings

Core Competencies
• Strong analytical and problem-solving ability
• Clear written and verbal communication
• Ability to work independently and collaboratively
• Effective project coordination and time management

EEO: “Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”