Eng II, Acute Disposables

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Skills you'll use

What you'll do

• You will be supporting the team responsible for developing solutions to challenging issues associated with the design, development, and sustenance engineering for our new and existing Disposables for the Acute Therapies portfolio focused on Lab testing and administration. You will have an independent responsibility to plan and execute formal V&V testing of Acute Disposables compliant to all the requirements, state-of-the-art methods and standards. Candidate needs to work with R&D engineers to help build Test fixtures/assemblies and assisting with Lab logistics. The candidate will also be a part of Lab Management team to ensure the Laboratory controls are in place in line with applicable international standards and guidelines. You will be expected to support and contribute to the Projects/Initiatives involving Lab testing for Product quality issues, root cause analysis, Test Method development, verification & validation, Design of Experiments testing.

Who can apply

• Diploma or Bachelor's Degree in Mechanical engineering / Biomedical Engineering / Polymer Engineering Related disciplines of Engineering
• Overall 4 to 8 yrs of experience with minimum 2 years in Medical Device Verification testing [Mechanical Hardware/Disposables].
• Experience in Lab Management and establishing Laboratory controls in line with International Standards regulations [FDA].
• Experience in developing the Procedures and Processes for Engineering labs and Testing facilities. Relevant technical testing/reliability experience in electro-mechanical 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; mechanical, functional, and environmental testing environments.
• Experience in medical device or similar product development, design verification/validation, system integration (involving software & hardware), risk management, reliability engineering, process validation
• Quality systems Basic understanding of and adherence to FDA, ISO and IEC design control procedures, regulations, and standards.
• Experience in facing internal/External Audits.
• Self-motivated, Good stakeholder management and effective communication skills.

About Vantive

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