Test Engineer

The Planet Group; Boston (MA); On-site; USD 85,000 - 110,000; Full time

Job summary

The Planet Group in Boston is seeking an experienced Test Engineer to translate requirements into testing designs for disposable medical devices, balancing technical constraints with schedule and cost.

You will develop test plans, evaluate requirements, coordinate lab activities, analyze data, and apply SOPs under FDA QSR, CE, and ISO guidelines.

Qualifications

• Minimum 2 years of engineering experience.
• SolidWorks proficiency.
• Execution hands-on role.

Responsibilities

• Synthesizes requirements and/or design specifications into testing solutions for disposable medical device products considering technical, schedule and cost constraints.
• Designs, develops and executes test plans, procedures, schedules, and test protocols to evaluate the design per specifications.
• Reviews and evaluates test requirements to ensure completeness of the test program.
• Coordinates integrated testing activities including labor, space and equipment with relevant areas or vendors.
• Provides assessment to engineers, technical lead, or project manager and adjusts plan as required.
• Implements project management practices to keep stakeholders informed.

Skills

Engineering experience

Hands-on execution

Education

Bachelor's degree in engineering

Bachelor’s Degree in Mechanical, Biomedical, or Materials Engineering

Tools

SolidWorks

Job description

• 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.
• 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

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.