Test Engineer

We’re seeking a hands-on Test Engineer to support the development and testing of disposable medical devices within a fast-paced R&D environment. This role will be responsible for developing, validating, and executing testing solutions that evaluate product performance against design specifications while ensuring compliance with FDA and ISO quality standards., * Develop, validate, and execute test methods, protocols, and procedures for medical device products.

• Design and perform testing to evaluate product performance against engineering specifications and requirements.
• Analyze test data and document results, conclusions, and recommendations.
• Apply statistical analysis and experimental design principles to testing activities.
• Support the design and fabrication of test fixtures, prototypes, and developmental assemblies.
• Maintain R&D laboratory organization, calibration records, and preventative maintenance schedules.
• Identify, procure, calibrate, and utilize laboratory equipment and tools.
• Coordinate testing activities, equipment needs, and resources with internal teams and external vendors.
• Prepare technical reports, presentations, and status updates for engineering leadership and project teams.
• Troubleshoot technical issues and recommend improvements to test methods, equipment, and processes.
• Ensure all work is conducted in accordance with FDA Quality System Regulations, ISO standards, SOPs, and applicable medical device development procedures.
• Collaborate closely with product development engineers, suppliers, and cross-functional stakeholders to support project objectives.

AutoCAD Machining Visionary Leadership Innovation Collections Fabrication Calibration Data Analysis Presentations Investigation Microsoft Excel Medical Devices Microsoft Office Test Engineering Technical Issues ISO/IEC Standards Method Development Equipment Operation Experimental Design Microsoft PowerPoint Statistical Analysis Laboratory Equipment Test Data Generation Design Specifications Biomedical Engineering New Product Development Quality Management Systems Engineering Design Process Medical Device Development Verbal Communication Skills Troubleshooting (Problem Solving) Engineering Plans And Specifications

At least 2 years, The ideal candidate will have a strong engineering foundation, experience with test method development and data analysis, and the ability to work collaboratively with cross-functional product development teams. This is an execution-focused role requiring significant laboratory and hands-on testing experience., * Bachelor’s degree in Engineering or related technical field.

• Minimum of 2 years of engineering experience.
• Experience with SolidWorks.
• Strong hands-on mechanical testing and troubleshooting experience.
• Ability to develop and execute test protocols independently.
• Excellent written and verbal communication skills.
• Experience working with Microsoft Office Suite (Excel, Word, PowerPoint)., * Bachelor’s degree in Mechanical, Biomedical, or Materials Engineering.
• Experience performing statistical analysis and applying Design of Experiments (DOE) principles.
• Experience in medical device development under FDA Quality System Regulations.
• Familiarity with Minitab.
• Experience with machining or working in a machine shop environment.
• Experience with AutoCAD and eDrawings.

Desired Technical Skills

• Test method development and validation
• Mechanical testing and fixture design
• Root cause investigation and troubleshooting
• Data collection, analysis, and reporting
• Experimental design and statistical analysis
• Laboratory equipment operation and calibration
• Regulatory compliance in medical device environments, Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.