Description
Position Summary:
This engineer works within or on the test and reliability team and/or a project team, generally within the molecular R&D project group . This engineer uses experience and education to perform the types of engineering activities which are generally considered within the realm of test and reliability engineering and any other expertise that might be held by this particular individual. This engineer is expected to work and communicate well with other team members and leadership as assigned in order to meet the goals of the project, the department, and the company.
Principal Job Duties and Responsibilities include but are not limited to the following:
- Perform all work in compliance with company policy and within the guidelines of bioMerieux Quality System.
- General: uses experience and education to perform the types of engineering activities which are generally considered within the realm of test and reliability engineering.
- Description: Uses engineering concepts, company SOPs/WIDs, department SOPs/WIDs to solve a variety of difficult engineering problems across functional groups and disciplines.
- Works on: problems of moderate scope and complexity. Generally works on a team with other engineers.
- Influence: receives some oversight from a Senior/Principal Engineer and/or Manager, may be eligible to be a discipline lead on a project, may provide mentoring for other engineers.
- Makes design and technical decisions subject to review by Senior, Principal, and other engineers.
- Develop and maintain test protocols and test plans throughout the development cycle (utilizing Helix ALM) for electrical and mechanical sub level testing and electromechanical system level testing.
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- Design Verification Testing
- Design Validation Testing.
- Process Validation Testing.
- Developing Test Fixture Designs.
- Participate in and conduct Engineering product design reviews and investigations
- Perform Root cause analysis on failures observed during testing.
- Responsible for development of testing throughout product life cycle, including: reliability testing, ship testing, environmental testing, accelerated life testing, HALT/HASS testing, altitude testing.
- Development of WIDS and SOPS for testing
- Performs other duties as assigned.
- Ability to adjust or move objects up to 50 pounds in all directions.
Travel: minimal travel required.
Team: usually works on a team with several engineers and a project manager.
Education & Experience Requirements:
- B.S. in Engineering or Equivalent.
- 5+ years of experience in an engineering field, testing field preferred.
Demonstrated Knowledge, Skills & Abilities:
- Strong Analytical Skills
- SolidWorks
- FDA Regulated Industry
- Helix ALM
- Design Verification/Validation Testing
- Process Validation Testing
- Test Protocol Development
- Test Fixture Design
- Design Controls
- Root cause analysis
- Excellent testing and "hands on" development aptitude
- Experience designing, writing and analyzing engineering studies, investigations, DCN's and CO's
- Developing life cycle tests and accelerated life testing
- Ability to work effectively both in a team setting and individually
- Statistics:
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- Minitab experience
- Knowledge of Reliability demonstration test plans
- Hypothesis Testing
- Gage R and R
- Designing and Analyzing DOE's
- HALT/HASS test fixture development and analysis
- Preferred to have experience with designing tests and fixtures for an ED vibration table
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