Senior Process Engineer

Senior Process Engineer


Senior Process Engineer

Details of the offer

The purpose of this position is to fulfill iRhythms manufacturing departments need for a full time technical expert in manufacturing process engineering. The Senior Manufacturing Process Engineer will provide manufacturing support for existing processes and for new products, product changes, line extensions and enhancements, as well as related tooling fixtures.

Support of new and existing manufacturing processes, new products, product changes and enhancements, as well as related tooling and fixtures.
Support prototype and pilot production, facilities and planning, when appropriate.
Interfaces with other departments to solve production problems.
Investigation and testing of product processes
Lead manufacturing efforts associated with new product transfer between R and D and manufacturing.
Drafts and executes validation of product, equipment and processes
Manages builds for new product development in prototype and pilot production setting, including training of operators and coordination with production planning as needed
Analyze data and improve processes to assure robust/repeatable manufacturing processes
Confers with appropriate departments, resources, and/or outside services to prepare process modifications, clarify problems and develop processes
Review and develop manufacturing documents
Provide solutions to complex problems including, but not limited to, those related to process, equipment, material, supply chain, documentation, equipment validation, IQ/OQ/PQ, PLM, and other applicable QMS/business processes.
Perform root cause analysis and implement process improvements to improve manufacturing yield.
Prepare and review manufacturing procedures, test protocols and reports, and other controlled documentation.
Support the design and development of tooling and fixtures to effectively manufacture new and existing products.
Searches and implements new technologies to improve manufacturing processes and equipment design
Demonstrated analytical skills with the ability to present data in meaningful and relevant fashion to aid in decision making process
Establish and maintain data monitoring for key processes, ie, FYPs, CPKs etc.
Experience with risk:based failure mode analysis
Excellent written and verbal communication skills

About you:

Bachelors Degree in Engineering or a related field required; Masters degree preferred
Must have at least 5:10 years of related experience
Experience with Continuous Process Improvement and Process Validations within a medical device manufacturing environment
Proficiency in Solidworks, Labview and fixture/tooling design preferred
Strong creative and critical thinking skills
Ability to work in a fast:paced, cross:functional environment
Some travel may be required : must be able to travel within the US
Experience working in ISO 13485 and FDA regulated environments
Desired Qualifications
Successful completion of a process validation a must
Supervisory experience and/or experience leading a team or project a plus
Knowledge of Lean and Six Sigma concepts and root cause tools a plus



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