Lead Test Engineer

Danaher Corporation•Marlborough, MA

1d•$85,000 - $100,000•Onsite

About The Position

The Lead Test Engineer is responsible for verification and validation of systems and products to ensure they meet required standards and specifications. The role plans, executes, and documents tests, analyzes results, and manages defects. It also supports line extensions of existing products and new product introductions for the R&D team in Marlborough, Massachusetts. The position reports to the Verification & Validation Manager, is part of UpStream RnD, and is onsite.

Requirements

Bachelor’s degree in Biomedical, Chemical, or Mechanical Engineering, or a related field.
At least 4 years of post-academic experience in engineering, bioprocess, or a related field.
Experience working within an ISO 9001/13485 and/or cGMP environment, and with Risk Management ISO 14971.
Knowledge of statistical analysis, DOE, impact assessment, root cause analysis, and risk management/FMEA.
Understanding of bioprocess engineering principles and methodology.
Effective written and verbal communication skills and the ability to collaborate across all levels within a global, multidisciplinary team.

Responsibilities

Develop comprehensive test plans outlining testing scope, approach, resources, and schedule.
Perform tests according to test plans, including functional, performance, and reliability testing.
Analyze test results to identify defects and verify that systems meet requirements.
Track and manage defects throughout the testing lifecycle and ensure they are resolved in a timely manner.
Model and design parts and assemblies in CAD, and create and modify drawings.
Work with development, quality assurance, project management, and other departments to support product integration and delivery.