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Lifecycle Engineer
This role leads projects and provides technical support for lifecycle activities related to medical device manufacturing. The engineer will interface with external manufacturers, manage change initiatives, and ensure smooth coordination across cross-functional teams including R&D and Equipment Development.
Key Responsibilities:
Lead and execute lifecycle projects with external partners
Plan and coordinate engineering phases, including validations and process improvements
Develop and validate test methods and equipment processes
Apply root cause analysis, statistical tools (DOE, Six Sigma), and problem-solving techniques
Manage non-conformances and CAPAs
Write clear production instructions and support associate training
Travel occasionally between local manufacturing and distribution sites
Qualifications:
Bachelor’s degree in Engineering or related scientific field
Minimum 4 years of product/process engineering experience
Experience in a regulated industry (medical devices preferred)
Strong cross-functional collaboration and conflict resolution skills
Proven ability to manage multiple priorities and deliver projects on time