Manufacturing Operations engineer
Santa Ana, CA
Industry: Medical devices
University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
Adapts machine or equipment design to factory and production conditions.
May incorporate inspection and test requirements into the production plan.
Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques.
Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
Ensures processes and procedures are in compliance with regulations.
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University)
Manufacturing engineer, Operations engineer OR Manufacturing Operations engineer
Must to have:
Regulatory Submissions / Global Regulatory Submissions
FDA 510(K), PMA Submission
Medical Device Registration/Re-registration, Renewal
Product Registration Support- APAC, LATAM, EMEA, Canada, China, Russia
Health Canada, TGA, HAS, CFDA/NMPA, TFDA, PMDA, Anvisa ANMAT, MFDS, MOHW, SFDA, MOH
Change submission, notifications
Regulatory licenses renewals
EU MDR Tech documentation Summary
RAC Certification: Medical Devices
Good To Have
US and EU Submission
Worldwide regulatory agencies/authorities
CE Technical File / EU Technical File / Design Dossier
Support EU MDR Transition activities
EU MDR Gap Analysis
Collateral/Product specific IEC Standards Knowledge
4+ with BS in Mechanical Engineering or Sciences degree
2+ with MS in Mechanical Engineering or Sciences degree
• IQ, OQ, PQ -Validation report
• Risk documentation - Design and process
• Manufacturing process and design controls
• SAP - material and part creation and tracking
• Very good written and oral communication in English.
• Ease for reading/creating/modifying documents.
• Able to work with minimal supervision. Self-motivated team player.
Valid through: 9/1/2020