Verification and Validation Engineer
V&V Engineer career opportunity at MiniFAB.
MiniFAB is currently recruiting for a Verification and Validation Engineer to join their team on a full-time, permanent basis. The V&V Engineer will be engaged in verifying product designs and validating manufacturing processes in line with regulatory requirements and internal quality standards. This position will provide support to the product development and new production introduction teams to meet project deliverables in the completion of development testing. Project deliverables may include producing and / or reviewing verification and / or validation plans, protocols, and reports; execution of the plans and protocols; and resolving deviations.
- Work closely with all engineering disciplines including Product Development, New Product Introduction, Manufacturing and Quality to generate, review, and approve verification and validation deliverables
- Assists with developing and implementing validation plans for new and existing production capabilities
- Streamlines qualification protocols and generation process
- Generates and performs qualification protocols and produces validation reports
- Define and develop test systems and ensure that all test systems and equipment are appropriately validated and controlled
- Assumes responsibility for aspects of the calibration program on an as needed basis
- Track and report on progress toward completion of verification and validation
- Encourages and suggests process improvements
- Completes other tasks as assigned
Essential Skills and requirements:
- Degree in Engineering or other related discipline
- Significant experience in design verification or validation, with an emphasis on medical devices
- Strong working knowledge of GMP regulations and ISO13485 and have sufficient experience with manufacturing equipment and utilities to understand how to design efficient qualification and validation protocols. Experience creating verification and validation plans, protocols, and reports
- Experience with requirements management, risk based testing approaches, defect tracking, and configuration control tools
- Understanding of engineering best practices and test methodologies
- Demonstrated capability to solve technical problems
- Medical equipment or other equipment experience involving complex, multi-component systems desired
- Experience with automation tools for testing applications (Labview, Matlab)
- Ability to work effectively and independently to ensure that validation programs are completed on time and with efficient use of resources.
- Manage multiple tasks and priorities simultaneously and adapt to changes in program priorities
- Excellent communication and interpersonal skills
- Keep up to date with new technologies as applicable to projects
- Test experience in medical products is highly desirable
Applications in Word Format will only be considered (No PDF Documents please).
Kindly note that due to the high number of applicants, only short listed Candidates can be contacted.
Questions can be directed to Leah Creswick at Fuse Recruitment Melbourne on 0478 193 170.