Validation Engineer

***SEEKING PROCESS VALIDATION ENGINEER***

Description:

This Process Validation Engineer will support the work for a new product accessory for a valve replacement device. This engineer will report to the product development manager and be supported by other manufacturing engineers as well quality engineers. This engineer will be tasked with supporting the process validations for this new product. Will be writing and authoring the validations for IQ,OQ,PQ.

Key Responsibilities

1. Fully participates in and successfully contributes to project teams typically including the following activities: product design and development, test of materials, preparation of specifications, process capability studies, research investigations (animal and clinical studies), report preparation, and process/test documentation.

2. Works independently to plan and schedule own activities necessary to meet timelines.

3. Designs and coordinates standard engineering tests and experiments.

4. Designs, procures, and fabricates tooling and fixtures.

5. Performs troubleshooting on new products/process problems as related to design, material, or process.

6. Summarizes, analyzes, and draws conclusions from test results.

7. Prepares standard reports/documentation to communicate results to technical community.

8. Responsible for engineering documentation.

9. Invents/ creates concepts and designs for new products/processes and submits idea disclosures.

10. May train and/or provide work direction to technicians.

11. Works cooperatively with process development, quality, manufacturing, regulatory, clinical, and marketing to ensure project success.

12. Demonstrates PDP/TPD system knowledge through delivery of high-quality deliverables.

Additional Skills & Qualifications:

Nice to Haves:

1. Windchill experience

2. Thermoplastic experience - highly preferred

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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