drjobs Validation Engineer - Contract

Validation Engineer - Contract

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Job Location drjobs

Kalamazoo, MI - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Validation Engineer (Contract) Kalamazoo MI

DISHER is currently looking for a Validation Engineer for our medical device customer in Kalamazoo MI. This can be a direct hire or contract role anticipated to last about 3 years.

In this role you will manage inspect calibrate test and modify the instrumentation equipment mechanics and procedures used to manufacture many products.

What its like to work here:
Our customer is a global leader in medical technologies and together with their customers is driven to make healthcare better. The company offers innovative products and services in MedSurg Neurotechnology Orthopedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world our customer impacts more than 150 million patients annually.

What you will get to do:

    • Provide engineering support for new product and process introductions ensuring that all activities are completed and documented in accordance with the companys new product development procedures
    • Ensure quality of process and product as defined in the appropriate operation and material specifications
    • Select components and equipment based on analysis of specifications reliability and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols.
    • Lead/support capital acquisition activity from specifying equipment contract negotiation Installation and validation.
    • Work with quality engineers to develop component specific testing and inspection protocols
    • Analyze equipment to establish operating data and conduct experimental test and result analysis
    • Lead process review meetings
    • Lead PFMEA Control Plan SOP and PPAP generation associated with product transfers and launches
    • Complete capability studies for in process inspection and generate subsequent inspection documentation
    • Conduct process validation and MSA studies for new products and new processes
    • Work in a handson manner at the manufacturing site to lead the implementation of new processes as specified in development
    • Provide training for manufacturing team members
    • Ensure adherence to GMP and safety procedures
    • Review and approval of validation documentation

What will make you successful:

    • Bachelors degree in engineering required
    • 4 years of applicable work experience required
    • Specialization or work experience in plastics or polymers
    • Experience in working with medical devices is preferred
    • Working knowledge of PFMEA required
    • Excellent analytical skills ability to plan organize and implement concurrent tasks required
    • Good knowledge of validation and manufacturing processes materials product and process design required
    • Ability to read and interpret complex engineering drawings and understand geometrical dimensioning and tolerancing (GD&T) required
    • CAD experience
    • Hold a current and continuing right to work in the U.S. without restriction or sponsorship

Employment Type

Contract

About Company

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