Job Description: SummaryEngineering Services provides innovative product testing and measurement solutions quickly and accurately to help achieve objectives in new product development, product improvements, regulatory compliance, and to help the business make data-based product decisions.
The Senior R&D Test Engineer contributes to the achievement of R&D goals through excellence in product testing. The engineer develops product testing solutions, improves current test methods, and may perform physical testing of clinical specimen collection medical devices. Reports to the Manager of Engineering Services.
Collaborate with product engineering teams to create testing solutions that satisfy product requirements and design intent. Fulfill other unmet needs in product testing throughout the Preanalytical Systems (PAS) business. May represent Engineering Services in providing solutions to difficult testing issues.
Develop and validate test methods.
Write test plans, protocols, and reports.
Design and perform measurement system analysis.
Apply DFSS methodology in test method development.
Design, document, and develop test fixtures.
Independently plan and perform experiments that support product or technology feasibility testing.
Execute tests, critically analyze data with statistical tools, make conclusion and report.
Specify new test equipment by writing user requirement specifications.
Perform risk analysis and mitigation for test equipment and methods.
Validate test equipment for GxP use.
Perform software validation of computerized laboratory equipment.
Promote good laboratory practices (GLP).
Be a thought leader on analytical laboratory instruments.
Help to advance the state of the art in PAS laboratory capabilities.
Bachelor's Degree in Mechanical Engineering, Biomedical Engineering, Applied Physics or similar discipline.
Experience: Four years of experience as an engineer, preferably with experience in a laboratory testing environment. A combination of less than four years of experience with notable accomplishments may be considered.
Excellent written & verbal communication skills
Operation of mechanical measurement equipment (e.g. Instron).
Experience in mechanical and other physical testing of medical devices
Proficient in statistical analysis using software such as Minitab
Design for Six Sigma
Fixture design using CAD
Working knowledge of 21 CFR 820 Quality System Regulations (including design controls and document controls).
Working knowledge of Good Laboratory Practices
Lab equipment software validation and LIMS (laboratory information management system) experience is preferred.
Able to lift 50 pounds.
Primary Work LocationUSA NJ - Franklin Lakes
BD (Becton, Dickinson And Company)