Continuous Improvement Engineer, Staff - P32-132

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 our employees can develop broad skill sets and directly influence product development and manufacturing outcomes.

We are looking for a Staff, Continuous Improvement Engineer reporting to Lee Marske to join our talented team in Alajuela, Costa Rica.  

Position Summary

The Staff Continuous Improvement Engineer plays a key role in driving operational excellence across manufacturing operations within a contract medical device environment. This position leads mid- to large-scale improvement initiatives using Lean, Six Sigma, and data-driven methodologies to improve quality, reduce waste, enhance throughput, and strengthen compliance to medical device regulatory requirements (ISO 13485, FDA 21 CFR 820). The ideal candidate is a proactive problem solver who works cross-functionally to standardize processes, enable sustainable improvements, and build a culture of continuous improvement.

Key Responsibilities

Continuous Improvement Leadership

• Lead and execute process improvement projects of moderate to high complexity using Lean and Six Sigma tools (e.g., DMAIC, VSM, Kaizen, SPC).

• Identify operational inefficiencies and develop data-driven solutions to improve yields, reduce defects, and enhance productivity.

• Facilitate Kaizen events, root cause investigations, and problem-solving workshops.

Operational Excellence & Standardization

• Develop and implement standardized work, visual management tools, and 5S systems across production areas.

• Partner with Production, Quality, Engineering, and Supply Chain to implement best practices and ensure process sustainability.

• Support deployment of continuous improvement strategies aligned with business and customer objectives.

Data Analysis & Performance Tracking

• Analyze production, quality, and cost data to identify trends and recommend corrective actions.

• Build dashboards, metrics, and reporting tools to monitor performance and progress toward improvement goals.

• Validate process capability and drive reduction of variation through SPC and statistical analysis.

• Research, review, pilot and deploy Innovative tools (ex. AI driven) to improve the efficiency and effectiveness of data analysis and decision making.

Regulatory & Quality System Support

• Ensure all improvement activities comply with medical device regulations (ISO 13485, FDA 21 CFR 820).

• Support process validation activities including IQ/OQ/PQ development and execution.

• Document project outcomes, process changes, and risk assessments per QMS requirements.

Cross-functional Collaboration

• Coach and mentor VSMs, supervisors, technicians, operators, engineers and Support Functions in Lean tools and continuous improvement principles.

• Serve as a subject matter expert supporting cross-site initiatives and customer-driven improvement efforts.

• Participate in audits, customer visits, and operational reviews related to process performance.

Qualifications

Required

• Bachelor’s degree in Engineering (Industrial, Mechanical, Manufacturing, or related field).

• 5-9+ years of experience in manufacturing, operations, or process engineering (medical device or regulated industry preferred).

• Demonstrated experience applying Lean and/or Six Sigma methodologies; Green Belt required, Black Belt preferred (or equivalent experience).

• Strong analytical skills with experience in statistical tools (Minitab, JMP, or similar).

• Knowledge of process validation, PFMEAs, control plans, and root cause analysis techniques.

• Excellent communication and facilitation skills, with proven ability to influence cross-functional teams.

• Bilingual proficiency in English and Spanish.

Preferred

• Experience in a contract manufacturing environment for medical devices.

• Background in plastics, machining, assembly, or high-mix/low-volume operations.

• Experience with ERP/MES systems and operational dashboards.

• Project management certification or training.

Competencies

• Continuous Improvement Mindset

• Technical Problem Solving

• Statistical and Analytical Thinking

• Cross-functional Collaboration

• Project Leadership

• Change Management

• Strong Documentation Discipline

• Customer Focus

Working Conditions

Combination of office and manufacturing floor environments. May require up to 25% travel to customer sites or other company facilities, depending on position location. 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.