Associate Lab Engineer
4 weeks ago
In this role, the Associate Lab Engineer will work under the direction of the Lab Supervisor to assist with test equipment qualifications, test fixture/jig design, test method development, and test method validations. This individual will bring excellent analytical, engineering, and organizational talent to the execution of development projects at West.
Key Responsibilities- Develop test methods and plan and coordinate test method validations/Gage R&Rs.
- Assist with figure and jig design in SolidWorks.
- Ensure lab equipment and environmental chambers are properly installed and qualified (IQ/OQ).
- Work closely with the Lab Supervisor, Verification Engineers, and Lab Technicians to plan and coordinate testing needs.
- Prepare test samples according to work instructions and procedures for engineering and verification testing.
- Write technical documents such as work instructions, test plans, protocols, and reports.
- Perform data analysis, as needed, for technical reports.
- Recognize inefficiencies and take initiative to improve processes and implement procedures to streamline workflows and increase effectiveness.
- Maintain a clean and tidy laboratory environment that is audit-ready at all times.
- Exhibit regular, reliable, punctual and predictable attendance.
- Demonstrate a "Customer Service" attitude when interacting with internal and external customers.
- Conform with and abide by all regulations, policies, work procedures, instruction, and all safety rules.
- Required minimum education: Bachelor's degree in engineering or laboratory discipline, or relevant equivalent experience.
- Required minimum experience: 0-3 years of experience.
- Preferred Knowledge, Skills and Abilities:
- Excellent problem-solving skills as well as keen analytical abilities.
- Excellent technical writing skills.
- Experience in laboratory testing of electromechanical devices, specifically medical devices in accordance with FDA regulations.
- Knowledgeable in test method validations, specifically Gage R&R
- Knowledge of Statistics and experience using Minitab a plus.
- Proficient in SolidWorks a plus.
- Proficient in MS Office suite including PowerPoint, Word, Excel and Outlook.
- Knowledge of ISO 13485 – Quality Management Systems for Medical Devices.
Up to 10%
Physical & Mental RequirementsLight – exerting up to 20lbs/9kg of force frequently, and/or negligible amount of force frequently constantly to move objects. If the use of arm and/or leg control requires exertion of force greater than that of sedentary work and if the worker sits most of the time, the job is considered light work
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