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Senior Manufacturing Engineer

hace 2 días

Alajuela, Alajuela, Costa Rica Theragenics Corp A tiempo completo

Be part of a mission that matters, join Theragenics as a Senior Engineer in Costa Rica and help lead the development of life-saving radiopharmaceuticals used in cutting-edge cancer treatments. In this critical role, you'll apply engineering expertise to optimize production systems and support the advancement of precision-targeted therapies, contributing directly to medical technologies that improve and extend lives. If you're passionate about innovation, technical leadership, and making a meaningful impact in healthcare, this is your opportunity to help shape the future of patient care.

Company Overview:

At Theragenics, we're passionate about transforming healthcare and enhancing patient outcomes. Our commitment to innovation drives us to push the boundaries of what's possible, ensuring a brighter future for patients everywhere. Theragenics is a leader in developing medical devices that focus on minimally invasive treatments for cancer, blood vessel procedures, and surgical applications. The company is based in Atlanta, Georgia, and has facilities in Costa Rica, Texas, and Massachusetts. Theragenics proudly operates Arrotek, a visionary medical device design consultancy in the U.S. and Ireland, dedicated to pioneering minimally invasive solutions that enhance lives.

Role Summary:

Collaborate with Operations to identify and implement process improvement opportunities that ensure production goals are achieved. You will support the transfer of products into manufacturing, ensuring a high degree of process capability and smooth integration. Additionally, you will validate process changes through proper documentation and secure the necessary approvals in compliance with quality and regulatory standards.

Responsibilities

  • Supports Production area in troubleshooting process and deliver timely solutions for product development.
  • Responds quickly to the occurrence of defects and unplanned production downtimes due to equipment failures, process issues. Solves related problems to resume production.
  • Leads a team to investigate the root causes of process problems and implements corrective actions. Develops procedures to ensure product quality / process capability and reduces process variability ensuring consistency in Mfg. execution.
  • Reviews/Develops procedures to ensure accuracy and upgrades required by change orders in the documentation. Works with Production to develop production processes, standard operating procedures, and drawings.
  • Has relationships with R&D, sourcing, and supplier engineering to pursue new development projects as well as seek cost improvements on existing products.
  • Attends daily shift meetings and communicates by providing updates with various departments.
  • Performs nonconformance and corrective actions investigation from root cause all the way to effectiveness.
  • Responsible for creating, routing and execution of all engineering reports, including all the validation phases as of engineering studies, process development, installation, operational and performance qualifications.
  • Informs project status to all levels of organization, including performance, cost, and schedule updates.
  • Utilizes DMAIC, OpEx, and mistake proof methodologies in the development of manufacturing processes to implement processes that are 'born lean and capable'.
  • Facilitates ease of manufacturing to produce quality, cost effective products with optimized yields.
  • Evaluates/Changes existing product flow, investigates and identifies new technology developments including automation-based solutions, and other technical improvements to drive process improvements to enhance quality, safety, customer satisfaction, production standards, and cost efficiencies.
  • Develops budget and schedule for projects and manages them.
  • Monitors daily/weekly/monthly product key metric trends and develops action plans as required (i.e. scrap, equipment downtime).
  • Determine parts and tools needed, and its controls in order to achieve manufacturing goals and reduce costs.
  • Collaborate with the development and transfer of products. Manage the installation and proper performance of new processes and equipment.
  • Conduct verification and validation of new processes and modifications to ensure process capability.
  • Other functions might be assigned based on company's needs.

Requirements Education:

  • Bachelor in Engineering 
  • Bilingual: English and Spanish B2 level minimum
  • Postgraduate degree preferred 

Experience:

  • Minimum 5 years in a medical device manufacturing environment.
  • Experience with GMPs and ISO 13485.
  • Validation execution experience, process characterization, IQ, OQ, PQ
  • Desirable transfer experience

Why Join Us:

  • Career growth
  • Innovative projects
  • Collaborative culture
  • Competitive benefits
  • Purpose-driven work
  • Solidarity Association

 

Ready to make a difference? Apply today and be part of something extraordinary."