Manufacturing Engineer, Staff

Role Overview

As a Staff Manufacturing Engineer at Confluent Medical, you will play a pivotal role in bringing life-saving medical devices from concept to high-volume production. Located at our state-of-the-art facility in Alajuela, Costa Rica, this role exists to bridge the gap between complex product design and highly efficient, compliant manufacturing processes.

You will lead large-scale engineering projects, optimize manufacturing yields, and oversee the transfer of new products into production. If you are looking for a highly technical, hands-on role where your expertise directly impacts patient safety and product reliability, this position offers the autonomy to drive real change within a collaborative, global team.

What Success Looks Like

Your success in this role is measured by the stability, safety, and efficiency of our manufacturing lines. On a day-to-day basis and over time, you will:

• Lead and Optimize: Own complex manufacturing processes, identifying and resolving yield issues, bottlenecks, and equipment downtime using rigorous data-driven methodologies.

• Drive Validations: Author, execute, and approve Equipment Qualifications (IQ) and Process Validations (OQ/PQ) in strict compliance with FDA regulations and ISO 13485 standards.

• Support New Product Introductions (NPI): Collaborate closely with R&D and transfer teams to seamlessly scale new medical device manufacturing processes from design to sustained production.

• Analyze and Solve Problems: Lead structured root-cause investigations (such as Fishbone, 5 Whys) for non-conformances (NCMRs) and implement robust Corrective and Preventive Actions (CAPA).

• Mentor and Collaborate: Provide technical guidance to junior engineers and technicians, fostering a culture of continuous learning and process ownership on the production floor.

What You Bring to the Team

We are looking for an experienced engineer who thrives on solving technical challenges and values precision. To be successful in this role, you must meet the following criteria:

Must-Have Requirements

• Education: Bachelor’s degree in Engineering (Mechanical, Industrial, Chemical, Materials, or a closely related discipline).

• Experience: At least 4-5 years of hands-on engineering experience within the medical device manufacturing industry (or another highly regulated, high-precision industry).

• Validation Expertise: Proven experience writing and executing IQ/OQ/PQ protocols and reports within an ISO 13485 and FDA-regulated environment.

• Statistical Skills: Strong proficiency in statistical analysis tools (such as Minitab) for Design of Experiments (DOE), process capability (Cp/Cpk), and data-driven decision-making.

• Language Skills: Professional working proficiency in both English and Spanish, with the ability to write technical documentation and communicate effectively with global cross-functional teams.

Nice-to-Have Qualifications

• Certifications: Six Sigma Green Belt or Black Belt certification.

• Technical Specialties: Experience with specialized medical device processes, such as catheter assembly, polymer extrusion, laser welding, or Nitinol processing.

• Project Management: Experience leading cross-functional project teams using formal project management methodologies.

Why Confluent Medical?

At Confluent Medical, we design and manufacture the essential components of medical devices that save lives every day. We offer a professional, supportive work environment in Alajuela where you can grow your career, work with advanced manufacturing technologies, and collaborate with some of the brightest minds in the medical device industry.

If you are a detail-oriented engineer looking to make a meaningful impact, we encourage you to apply and join our team.