Job Title: Test Engineer 2 Location: Boston, on-site 4-5 days Shift: 9am-5pm PST Contract length: 12 months Schedule: Fulltime, M-F Pay: 45-50 Responsibilities • Synthesizes requirements and/or design specifications into testing solutions for disposable medical device products that acknowledge technical, schedule and cost constraints in support of R&D product development. • Designs, develops and executes comprehensive test plans, procedures, schedules, and test protocols to evaluate the design per specifications. • Reviews and evaluates test requirements to insure completeness of test program. • Coordinates integrated testing activities including required labor, space, and equipment with appropriate areas or vendors. • Provides assessment to engineers, technical lead, or project manager and adjusts plan as required. • Compiles data and defines changes required in test equipment, procedures, processes, methods, or new testing requirements. • Performs data analysis and documentation of test results. • May participate in design of test fixtures and testing of prototypes or developmental assemblies or systems. Essential Duties • Demonstrates solid/strong technical knowledge to independently select best methods and approaches to solve diverse and moderately complex problems and make accurate and effective technical decisions. • Solves complex problems under close supervision or with assistance. • Applies appropriate standards, processes, policies, procedures, and tools throughout the product/system development lifecycle, including Standard Operating Procedures (SOP's) and applicable medical device development protocols under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems. • Develops and validates moderately complex test methods, executes testing protocols, and incorporates statistics and principals of experimental design. • Maintains R&D lab organization, calibration records, and performs preventative maintenance of equipment and test fixtures. • Identifies, procures, calibrates, and appropriately uses laboratory equipment and tools, and clearly documents, communicates, and summarizes technical findings and results. • Implements project management practices as needed; communicate proactively, openly and cooperatively within the department, team, and with supervisory staff to keep all informed. • Prepares clear and timely written and oral status reports, updates, and technical presentations. • Makes technical presentations to supervisors and small groups and may assist others with presentations. • Interfaces with product development team, suppliers, and other technical and support personnel. • Applies and demonstrates understanding of customer needs, product use, and operational requirements to translate customer needs into testing design specifications and applications. • Applies basic understanding of specialized and/or interdisciplinary technical areas, project management, and system design. • Clearly communicates instructions and technical specifications, both orally and in writing. • Proactively identifies, communicates, and refers problems or coordination needs to senior staff or supervisors. • Exercising sound judgment of what to share, refer, and when to seek assistance, provides timely, accurate, and detailed background data to minimize risks or support problem-resolution or goal achievement. Must-Haves • Minimum 2 years of engineering experience • SolidWorks • Execution hands-on role • Engineering Degree Nice-to-Haves - Statistical Analysis Experience Qualifications • Required: Bachelor's Degree, BSE in technical field. • Preferred: Bachelor's Degree in Mechanical, Biomedical, or Materials Engineering. Experience • Required: 0-4 years' experience with medical device development under FDA Quality Systems Regulations. • Preferred: Experience with machining and working in machine shop environment is a plus. Proficiency • Demonstrated written communication skills • Strong verbal communication and listening skills • Troubleshooting and problem-solving skills with hands-on practical expertise • Proficient with lab equipment appropriate to technical field such as microscopes, Instron tensile testers, chemical hood, and noise & vibration analyzers. • Proficient with Microsoft Word, PowerPoint, Excel, and Minitab. • Proficiency in design packages appropriate to technical field such as SolidWorks, eDrawings, and AutoCAD is desirable.