Thermo Fisher Scientific Sr New Product Validation Engineer in Tewksbury, Massachusetts

Job Description

How will you make an impact?

The Sr. New Product Validation Engineer is responsible for creating and executing design verification and validation strategies on product/component testing, tracking product quality trends, data mining, testing protocol development and continuous product improvement support.

What will you do?

  • Represents Quality on New Product Development Teams (development of FMEA and Control Plans, data collection and analysis, etc.) with a focus towards achieving all defined quality performance goals.

  • Collaborate with other functional groups (R&D, manufacturing, engineering, etc...) to determine validation requirements and develop test plans for associated products, processes & equipment.

  • Analyze test results, identify and own actions to prevent/eliminate product and systemic quality problems.

  • Serve as initiator and owner of validation related change controls and corrective and preventative actions.

  • Responsible for the generation and maintenance of validation procedures, validation master plans and validation reports.

  • Provides training, guidance, leadership, and expertise to the quality and manufacturing organizations through application of methods for quality assurance and control, statistical tools, software, data capture, and analysis for performance measurement and improvement.

  • Accurately generates, analyzes, and reports on the levels of product quality within the assigned manufacturing areas, including Pareto, Statistical Process Control, and Process Capability Studies; Is responsible for conducting gauge R&R activities and the development and implementation of improvements to meet measurement system performance specifications;

  • Run tests with Thermal, Vibration, and other standard test equipment

  • Assist in deviation investigation and resolution of problems and issues encountered during field execution activities.

How will you get here?

Education

  • BSEE, BSME, Optical Engineer or other technical discipline

Experience

  • Minimum of 5 years of product test engineering experience (in addition to Co-Op/Intern experience)

  • Experience in the following industries preferred: environmental, pharmaceutical, automotive or other regulated industry

  • Experience with software validation is a plus

Knowledge, Skills, Abilities

  • Demonstrated understanding of systematic work practices and control documentation methodologies.

  • Ability to design and construct test fixtures as necessary

  • Skilled with statistical analysis and its application to design verification and validation.

  • Ability to effectively communicate information and risks clearly and concisely across multiple levels in the organization

  • Analytical, problem solving, and root-cause analysis skills.

  • A self-motivated, hands on team player with a desire to learn and share knowledge across the team

  • Travel up to 10%

  • Required to be a US Citizen or authorized to work in the United States

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.