Test Engineer (Boston)

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/noise 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.”