Intuitive
Job Description
Primary Function of Position
This role manages advanced manufacturing engineering projects, process validation and optimization, and compliance with medical device regulations for production scale-up and improvement.
Essential Job Duties
Lead process improvement and optimization projects for manufacturing lines.
Design and validate manufacturing processes and equipment per regulatory standards.
Analyze production data to identify and address performance gaps or inefficiencies.
Develop and execute equipment validations, IQ/OQ/PQ protocols.
Investigate and resolve process and equipment failures.
Manage change control and update technical documentation (SOPs, WI, BOMs).
Support new product introduction and transfer to manufacturing.
Mentor and train junior engineers and production staff.
Participate in regulatory audits and ensure compliance with FDA, ISO 13485.
Drive continuous improvement and cost reduction initiatives.
#J-18808-Ljbffr
This role manages advanced manufacturing engineering projects, process validation and optimization, and compliance with medical device regulations for production scale-up and improvement.
Essential Job Duties
Lead process improvement and optimization projects for manufacturing lines.
Design and validate manufacturing processes and equipment per regulatory standards.
Analyze production data to identify and address performance gaps or inefficiencies.
Develop and execute equipment validations, IQ/OQ/PQ protocols.
Investigate and resolve process and equipment failures.
Manage change control and update technical documentation (SOPs, WI, BOMs).
Support new product introduction and transfer to manufacturing.
Mentor and train junior engineers and production staff.
Participate in regulatory audits and ensure compliance with FDA, ISO 13485.
Drive continuous improvement and cost reduction initiatives.
#J-18808-Ljbffr