Sr. Manufacturing Engineer

South Bay, CA

Posted: 12/07/2018 Employment Type: Direct Hire Industry: Medical Device Job Number: JOS000008098

Responsibilities:

  • Improves manufacturing processes, methods and controls for cost reduction, quality improvements and efficiency for both sustained and new products
  • Prepares engineering change orders and coordinates the deployment of changes including training operation team members
  • Improves manufacturing process instructions, product flow, assembly methods, space allocation, product quality and safety performance for both sustained and new products
  • Coordinates the manufacturing launch of new products including establishing yield targets, run rates, training needs and evaluating results
  • Develops, tests and cost justifies various tools and equipment recommended for manufacturing methods
  • Performs product and process analysis for cost reduction, quality improvement and improved efficiency
  • Utilizes tools associated with risk management (PFMEA/Hazard Analysis) to identify potential risks and the associated corrective actions
  • Supports required equipment qualification/process validation
  • Troubleshoots processes when defects occur.  Determine root cause and implement effective containment and countermeasures.
  • Dispositions non-conforming products and develop re-work procedures
  • Communicates with customers regarding process improvements and production changes
  • Represents manufacturing on cross functional teams
  • Participates in Kaizens and drive improvement efforts
  • Other duties as assigned

Requirements:

EDUCATIONAL:

  • Bachelor’s degree in Engineering or related field required
  • Advanced knowledge of manufacturing and assembly processes
  • A minimum of 5-8 years of engineering experience in a Medical manufacturing environment
  • Previous experience and the ability to direct, lead and mentor engineers with respect to company engineering procedures, new product introduction, manufacturing support and tooling
  • Excellent verbal and written communication skills
  • Fluency in English

TECHNICAL:

  • Previous experience with Class III Medical devices, FDA standards, ISO 13485 and GMP principles preferred
  • Technical leadership experience managing engineering teams, budgets and resources throughout various design phases, development and implementation of a new products
  • Experience working cross functionally with other disciplines including engineering, quality, planning and scheduling
  • Ability to lead, train, and engage manufacturing team members to reach Cirtec’s quality standards
  • Must be able to read blueprints and interpret technical specifications and illustrations
  • Association with supporting documents including, ECN’s, process deviation, non-conformances, stop shipment notifications and all associated quality related documents
  • Strong computer skills associated with MS Office suite, Minitab and SolidWorks a plus
  • Experience associated with continuous improvement activities, including participations and/or facilitating Kaizen events using lean manufacturing principles
  • The ability to understand a range of engineering functions and procedures
  • A practical and logical approach to problem solving using lean six sigma concepts
  • Interpersonal, presentation and communication skills
  • Team working and people management skills
  • The capacity to work well under pressure and take on new challenges
  • Organizational and time management skills
  • Project management skills and the ability to work to tight deadlines
  • An awareness of health and safety issues
  • Willingness to travel, if required

TRAINING:

  • In house on the job training as required to meet job requirements.
  • Keep up with current industry technologies by attending training courses and conferences.

PERFORMANCE:

  • Decision Making and Problem Solving:  Must be able to make clear and accurate decisions.
  • Analytical Problem Solving:  Must be able to use a systematic approach to solving problems by researching and evaluating alternative solutions.
  • Interaction:  Must be able to communicate well, both verbally and in writing, and work well in a team environment.
  • Initiative:  Able to function with minimum supervision
  • Versatility:  Able to respond to changing priorities with minimum disruption.
  • Leadership:  Must be able to lead discussions and meetings with customers and staff related to job role.

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