Manufacturing Process Development Specialist

hace 9 horas

Alajuela, Alajuela, Costa Rica Cirtec Medical Corporation A tiempo completo

About Cirtec Medical Corporation

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Cirtec Medical Corporation is a comprehensive design shop and contract manufacturer that offers a unique range of vertically integrated capabilities. We specialize in complex, difficult to produce components and devices in advanced product technologies such as neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist and interventional devices and delivery systems.

We possess the necessary capabilities to bring products to full production, including assembly, packaging and testing, and in-house sterilization. Our team members have the expertise required to design innovative devices, solve complex design challenges, and help bring our customers' devices to market.

Job Summary

This position is primarily responsible for developing and implementing robust cost-effective manufacturing processes and methods in accordance with product specifications and medical device quality standards.

The ideal candidate will be able to recommend and implement improvements to sustained production processes, methods and controls; as well as coordinate the launch of new products into pilot production.

Main 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.">
  • Improve 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 and qualifies various tools and equipment required for manufacturing processes.">
  • Performs product and process analysis for cost reduction, quality improvement and improved efficiency.">
  • Utilizes tools associated with risk management (e.g. PFMEA) to identify potential risks and the associated corrective actions.">
  • Supports required equipment qualification and process validations (IQ, OQ and PQ).">
  • Troubleshoots manufacturing processes when defects occur. Determines root cause and implements effective containment and countermeasures.">
  • Disposes non-conforming products and develops re-work procedures.">
  • Communicates with customers regarding process improvements and production changes.">
  • Represents manufacturing on cross-functional teams.">
  • Participates in Kaizen events and drives continuous improvement efforts.">
  • Complies with company, quality and safety standards, policies, and procedures.">
  • Attends and schedules project meetings to determine current and future process initiatives.">
  • Supports site documentation and manufacturing procedures.">
  • Other duties as assigned.">

Qualifications

To be successful in this role, you must have a bachelor's degree in an engineering discipline and 2 years of experience; or a combination of education and relevant work experience.

You should have knowledge of manufacturing and assembly processes, excellent verbal and written communication skills, fluency in English, and prefer 2+ years of experience with Class II or III Medical devices, FDA standards, ISO 13485 and GMP principles.

A strong ability to read blueprints and interpret technical specifications and illustrations is essential, along with computer skills associated with MS Office suite, Minitab and SolidWorks.

Experience with continuous improvement activities, including participating and/or facilitating Kaizen events using lean manufacturing principles, is also preferred.

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