Continuous Improvement Engineer II

Job Description:

Confluent Medical Technologies is a financially healthy and rapidly growing medical device company whose employees are passionate about providing life-saving solutions to our customers through a collaborative and high-impact work environment. Our moderate size, diversity of technologies, and broad material science capabilities provide an environment in which employees can develop broad skill sets and directly influence product development and manufacturing outcomes.

We are seeking a Continuous Improvement Engineer II to join our team in Alajuela, Costa Rica. This role is an individual contributor position focused on executing continuous improvement initiatives and supporting operational excellence across manufacturing environments.

Position Summary
The Continuous Improvement Engineer II supports and executes continuous improvement initiatives across manufacturing operations within a contract medical device environment. This role applies Lean, Six Sigma, and data-driven methodologies to improve quality, reduce waste, enhance flow, and strengthen compliance with medical device regulatory requirements (ISO 13485, FDA 21 CFR 820). The position operates with moderate autonomy, contributing technical expertise to improvement activities while partnering closely with cross-functional teams.

Key Responsibilities

• Execute process improvement projects of low to moderate complexity using Lean and Six Sigma tools such as DMAIC, value stream mapping, Kaizen, and basic SPC.
• Identify inefficiencies in manufacturing and support processes and recommend data-driven solutions to improve safety, quality, cost, and delivery.
• Support Kaizen events root cause investigations, and structured problem-solving activities.
• Develop and implement standardized work visual management tools, and 5S practices within production areas.
• Partner with Production, Quality, Engineering, and Supply Chain to ensure improvement actions are implemented, sustained, and documented.
• Research, review, pilot and deploy Innovative tools (ex. AI driven) to improve the efficiency and effectiveness of data analysis and decision making.
• Analyze production, quality, and cost data to identify trends, gaps, and opportunities for improvement.
• Create and maintain metrics dashboards, and reports to track progress against improvement objectives.
• Apply basic statistical tools to assess process capability, variation, and performance.
• Ensure improvement activities comply with ISO 13485 and FDA 21 CFR 820 requirements.
• Support process validation activities including documentation and execution of IQ, OQ, and PQ, as applicable.