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
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