Process Development Engineer

Role Overview The Process Development Engineer at nextern in Cartago, Costa Rica, plays a central role in shaping efficient and compliant manufacturing systems. This position focuses on designing, implementing, and refining production processes to boost speed and quality, while meeting international regulations and industry standards. Main Responsibilities A…

Role overview The Process Development Technician at nextern plays a key role in supporting both product creation and process improvement at the Cartago, Costa Rica facility. This position centers on effective document and data management, coordinating training, and upholding compliance with product and process standards. The role involves hands-on work in manufacturing environments, including cleanroom settings, and close collaboration with multiple teams. Main responsibilities Assist with product builds during pre-production phases in both cleanroom and standard manufacturing areas. Collect and analyze market research to inform new process and product development. Manage documentation and data processing to confirm products meet required specifications. Participate in planning and launching new manufacturing processes and products. Identify departmental needs and contribute to establishing process management and compliance procedures. Collaborate with manufacturing teams to provide product specifications and detailed production procedures. Help develop and implement quality control standards and safety protocols, encouraging team adherence. Engage in continuous improvement activities and monitor ongoing manufacturing processes. Assist with process and test method validations to ensure reliability and compliance. Support the selection, design, and procurement of manufacturing and testing equipment. Install and maintain production equipment and fixtures as needed. Apply understanding of cause and effect in process development tasks to drive improvements.

Role overview MGS Manufacturing Group Ireland Ltd. is hiring a Process Engineer for its Cartago, Costa Rica facility. This position plays a key part in daily production, focusing on process monitoring, equipment set-ups, and tool changeovers to help meet production goals and maintain efficiency. Main responsibilities Set up equipment and perform tool changeovers as part of regular production tasks. Carry out process validations, including PD, IQ, OQ, and PQ developments. Oversee process start-ups and monitor production runs to ensure targets are met. Handle process escalations and troubleshoot issues using a systematic root cause approach. Support and improve current processes through advanced troubleshooting methods. Contribute to continuous improvement efforts and assist with new projects. Help create documentation, training materials, and work instructions as needed. Maintain a safe and clean work area, ensuring machines and equipment comply with safety standards. Follow all Quality and GMP requirements and adhere to company policies and procedures. Requirements Education or qualifications in Engineering, Mechanics, or Electronics. Strong technical skills and a scientific approach to problem-solving, using analytical and experimental methods to drive productivity. Significant relevant experience in a similar process engineering role. Excellent communication and interpersonal abilities. Capable of working independently and within a team, with minimal supervision. Primarily day shift, but flexibility with working hours is required as site needs change.

Join Bluelight Consulting as a talented Full Stack Engineer specializing in both Python and React. In this fully remote position, you will be part of a dynamic team dedicated to building innovative solutions that make a real difference. You will leverage your expertise to develop robust applications and collaborate with cross-functional teams to deliver high-quality software.

Join Bluelight Consulting as a Laravel Developer with proficiency in React. This remote position invites talented developers from Latin America to collaborate on innovative projects that impact the digital landscape. You will work with a dynamic team to create robust applications, enhancing user experiences through clean and efficient code.

Join the innovative team at Bluelight Consulting, a premier software consultancy renowned for crafting transformative technology solutions that improve user experiences. Our unwavering dedication to exceptional client service and quality sets us apart as we strive not only to develop state-of-the-art applications but also to cultivate a collaborative, enriching work environment. Each team member is valued, fostering personal and professional growth in a vibrant community that spans the United States and Central/South America. As we continue our exciting expansion, we are on the lookout for extraordinary talent to enhance our diverse team.We are actively seeking a talented Senior Fullstack Engineer proficient in Python (Django) and React to become an integral part of our rapidly growing team. This role is perfect for a professional who thrives in a fast-paced, dynamic setting where every voice is heard and contributions are recognized. You will engage in meaningful projects that require developing high-quality applications that distinguish themselves in the competitive market. At Bluelight, we emphasize continuous learning, personal growth, and diligent effort, providing a collaborative atmosphere that promotes professional development. If you are passionate about software engineering and eager to contribute to a flourishing consultancy, we encourage you to apply and embark on this exciting journey with us.

Join our innovative team at Bluelight Consulting as a React Native Developer and work remotely from anywhere in Latin America! We are seeking a passionate and skilled individual who thrives in a collaborative environment. You will play a key role in developing high-quality mobile applications that enhance user experience and engagement.

Role Overview Nextern is hiring a Project Manager for Innovative Product Development based in Cartago, Costa Rica. This position guides product development projects from early concept through phase gate processes, manufacturing, and commercialization. The Project Manager shapes practical solutions to meet customer needs and supports the entire business development cycle. Regular collaboration with both new and established commercial partners is expected, with a strong emphasis on improving new product introductions. Main Responsibilities Coordinate new product development with customers and internal teams. Work alongside engineering leads and management to create and manage schedules, budgets, performance goals, resource plans, and task priorities. Monitor project timelines and budgets, address escalations, and coordinate solutions with stakeholders. Act as the main project management contact for team leads and key stakeholders, ensuring critical activities remain on track. Facilitate clear communication across departments, supporting collaboration between engineering and other groups. Review product designs and prepare required bills of materials. Work with supply chain teams to secure pricing for bills of materials from both internal and external vendors. Draft quotations and project scopes for management review and client delivery. Support the rollout of component and device testing protocols. Prepare accurate written reports as part of project documentation. Develop methods to evaluate process repeatability and stability, including equipment qualification and process validation. Coordinate activities across departments and manufacturing sites during pilot production of new products. Ensure all project stage gates are completed and projects comply with Nextern’s design and development processes. Maintain thorough documentation of all development activities to meet Design History File and ongoing production record requirements. Collaboration and Impact This role works closely with cross-functional teams to refine manufacturing processes and improve systems. The Project Manager helps deliver high-quality products at optimized costs and is central to maintaining strong communication and documentation throughout each project.

As a Quality Engineer at Nextern, you will play a crucial role in managing quality requirements between our organization and key clients. Your primary focus will be to ensure that customer quality expectations are met across engineering, production development, and the supply chain. You will balance responsibilities across various areas to achieve outstanding product quality while adhering to company standards, regulatory requirements, and customer guidelines.Lead investigations of complaints and Corrective and Preventive Actions (CAPA).Engage in direct communication with both internal and external clients.Conduct internal audits to ensure compliance.Drive updates to Quality Management System (QMS) documentation.Oversee validations and Test Method Validations (TMVs).Execute Initial Inspection Reports (IIR) and First Article Inspection Reports (FAIR) independently.Support engineering activities including Installation Qualifications (IQs), Operational Qualifications (OQs), and Performance Qualifications (PQs).Participate in new product introduction activities, providing support as needed.Assist quality functions in product development and transfer processes.Mentor team members in investigations and Root Cause Analysis methodologies.Provide assistance to various engineering areas with minimal support.Act as the Quality leader in development projects.

About Bluelight Consulting Bluelight Consulting is a software consultancy focused on building technology that improves user experiences. The team emphasizes quality and client satisfaction, with a collaborative work culture that supports skill development and professional growth. With a presence in the United States and Central and South America, Bluelight continues to expand and welcomes new talent to its diverse group. Role Overview: Outbound Sales Development Representative This remote position is based in Cartago, Costa Rica and plays an important part in Bluelight's growth across Latin America. The Outbound Sales Development Representative will focus on identifying and engaging potential clients, helping to drive the development of high-quality software projects that set Bluelight apart in the market. What You Will Do Identify and reach out to prospective clients across the region Engage in conversations that introduce Bluelight’s services and value Collaborate with team members to support sales initiatives Contribute to a positive, growth-oriented team environment What Bluelight Offers Opportunities to work on meaningful projects Support for continuous learning and personal development A collaborative culture where contributions are recognized Room for professional advancement within a growing consultancy Who Should Apply This role suits someone who enjoys proactive outreach, values teamwork, and is motivated by the chance to help shape a growing company. Experience in software development or technology consulting is a plus, but a willingness to learn and contribute matters most.

Role Overview nextern is seeking an OPEX Engineer - Continuous Improvement Expert for its team in Cartago, Costa Rica. This role focuses on driving improvements across manufacturing and production by applying Lean and Six Sigma methods. The position calls for close collaboration with cross-functional groups to deliver solutions that support business goals within a regulated setting. What You Will Do Analyze manufacturing and production processes to identify areas for improvement. Assess issues and select the most effective continuous improvement approach for each challenge. Develop and update detailed process documentation to support ongoing initiatives. Train and mentor staff in Lean principles and related tools. Work with teams across departments to deliver integrated solutions. Lead or facilitate 5S, Process Mapping, and Kaizen events or projects to achieve measurable outcomes. Track project progress and report performance metrics to senior management. Monitor key performance indicators for continuous improvement and take action to keep them relevant. Ensure all process improvements meet quality, regulatory, and safety standards.

Nextern is seeking a talented and motivated Manufacturing Engineer III to join our dynamic team in Cartago. In this role, you will spearhead product enhancement initiatives tailored to meet customer specifications, effectively resolve manufacturing challenges, and oversee the product lifecycle. You will collaborate with key stakeholders across various departments including operations, production, supply chain, and research and development to foster a culture of innovation and efficiency.Your contributions will be pivotal in refining our manufacturing methods and processes, ensuring the delivery of high-quality products at optimal costs.DUTIES AND RESPONSIBILITIES: Lead the coordination of product improvements with customers and internal project teams. Analyze high-level design requirements to determine alignment with Nextern's core competencies and vision; review designs and establish necessary Bill of Materials. Collaborate with supply chain teams to secure BOM pricing from both internal and external vendors. Address manufacturing issues pertaining to product quality and cost. Support customer interactions and presentations to compile activities for product sustainability. Generate comprehensive documentation to support product development and manufacturing processes, including timelines, responsibilities, engineering protocols, and reports. Assist in conducting testing protocols for components and devices. Develop plans to assess process repeatability and stability through equipment qualification and process validation. Ensure compliance with QSR and internal protocols in collaboration with quality, supply chain, and product development teams. Work alongside internal manufacturing and outsourced partners to establish metrics related to labor time, yields, statistical analysis, and process qualification. Facilitate the transfer of engineering projects into manufacturing as required.