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.”