This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
As Mechanical Lab Technician you would support infusion system Hardware Engineering. The individual will have an independent responsibility of following instructions clearly in executing test procedures, work with design engineers to help build test fixtures/assemblies and assisting with lab logistics. The candidate will also be a part of Lab Management team to ensures the Laboratory controls are in place in line with FDA guidelines.
Essential Duties and Responsibilities:
- Support Design engineers in Test fixture creation, Test set up readiness and test method validation
- Follow instructions and Test protocols with limited guidance from Design engineers during Test execution.
- Support in Developing and Executing Test Procedures/Functional Requirements testing/Performance testing.
- Good knowledge to use mechanical metrology equipment’s like height gauges, UTMs, Hardness testers
- Operate and maintain test equipment & Identify reason for equipment malfunction.
- Develop and Perform Design Verification & IQ/OQ/PQ,
- Diagnose, isolate, and investigate problem reports.
- Follow QMS, ensure good documentation and Good Manufacturing practices are followed in the Verification Process
- Support for Instrument Management and Calibration.
- Support consumable management/Logistics/ Tracking of parts.
- Support PM for Reliability equipment's and Thermal Chambers
- Follow safety guidelines and monitor the same for Lab operations.
- Trouble shoot equipment's and systems and perform RCA.
- Works with external test houses (such as IPX, Drop, Shock, Vibration EMI, EMC tests for electrical boards and full device) to define the test scope, author the test plans, test procedures, execute & consolidate the reports
- Experience in IEC basic safety, IPX, Drop, Shock, Thermal testing.
- Interacts with design team to resolve tests-related technical issues.
Qualifications & Key Skills:
- Diploma or bachelor’s degree in Mechanical Engineering
- Overall, 6 to 9yrs of experience.
- Experience in Lab Management and establishing Laboratory controls in line with FDA regulations.
- Experience in developing the Procedures and Processes for Device Engineering labs and Testing facilities. Relevant technical testing/reliability experience in electro-mechanical, electrical, devices.
- Identify and report any quality or compliance concerns and take immediate corrective / Preventive action as needed
- An understanding of test methods and processes as well as the methods used to verify product in the realms of software, mechanical, electrical, functional and environmental testing environments.
- Understanding of hardware and software product design methodologies and test practices.
- Experience in medical device or similar product development, design verification/validation, system integration (involving software & hardware), risk management, reliability engineering, process validation and Quality systems Basic understanding of and adherence to FDA, ISO and IEC design control procedures, regulations and standards.
- Experienced in facing internal/External Audits. Self-motivated with good interpersonal skills. Ability to follow instructions clearly.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
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