Test Engineer 2

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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.