Test Engineer 2

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.