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.
• Collaborate cross-functionally and participate in audits, customer visits, and operational reviews when required.
• Contribute to continuous improvement culture by learning, applying, and sharing Lean principles and best practices.

Qualifications
Required:
• Bachelor’s degree in Engineering (Industrial, Manufacturing, Mechanical, or related field).
• 2–5+ years of experience in manufacturing, operations, or process improvement roles, preferably in a regulated industry.
• Working knowledge of Lean Manufacturing and/or Six Sigma methodologies (Green Belt preferred or in progress).
• Basic proficiency with data analysis and statistical tools (e.g., Excel, Minitab, JMP).
• Familiarity with root cause analysis, PFMEAs, and process documentation.
• Effective written and verbal communication skills.

Preferred:
• Experience in contract medical device manufacturing.
• Exposure to high-mix / low-volume manufacturing environments.
• Experience working with ERP, MES, or production reporting systems.

Working Conditions
Combination of office and manufacturing floor environments. May require up to 25% travel to customer sites or other company facilities. Must be able to wear required PPE and work around typical manufacturing equipment.

Confluent Medical Technologies is dedicated to working collaboratively with our customers, taking their projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Our primary capabilities include: Nitinol components and tubing, balloon expandable stents and catheters, complex catheters, biomedical textiles, and high precision polymer tubing. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers.

We regret that we are unable to sponsor employment visas or consider individuals on time-limited visa status for this position.

Confluent Medical Technologies is an equal opportunity employer.

Only qualified candidates will be contacted.