Job Description:
Desired Qualifications:
SolidWorks or similar 3D modeling and design experience.
Project leadership/management experience and/or leading a team.
Knowledge of Lean and Six Sigma concepts and root cause problem solving.
About You:
Bachelor's Degree in Engineering or a related field required; Master's degree preferred
Must have at least 5+ years of related experience in the medical device or similar field.
Experience with Continuous Process Improvement and Process Validations within a
medical device manufacturing environment.
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.
Job Responsibilities:
Responsibilities include:
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&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/or develop manufacturing and engineering 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.
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 metrics in manufacturing.
Excellent written and verbal communication skills.
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