We are a Technical and Engineering staffing agency tasked with recruiting a Continual Improvement Engineer for our Orange County client. Our client is a globally recognized leader in the medical technology and healthcare equipment industry, best known for its pioneering work in noninvasive patient monitoring systems, advanced biosensor technology, and life-saving diagnostic platforms. With a strong presence in hospitals, surgical centers, and outpatient care facilities across the world, the company is committed to driving better outcomes through precision-engineered, FDA-approved medical devices.
Built on a foundation of continuous innovation and lean thinking, the organization is rapidly scaling operations to support global demand and is actively investing in world-class manufacturing, quality, and process optimization initiatives. They maintain ISO 13485-certified and FDA-compliant operations with a strong culture of operational excellence, data-driven decision making, and patient safety.
Typical Duties and Responsibilities
As a Senior Continuous Improvement Engineer, you will play a key role in identifying and implementing lean, Six Sigma, and operational excellence initiatives across the company’s global manufacturing and supply chain operations. Your focus will be on reducing waste, improving quality, increasing throughput, and elevating manufacturing efficiency in a regulated medical device production environment.
Key responsibilities include:
- Lead cross-functional kaizen events, value stream mapping (VSM), and root cause analysis (RCA) initiatives to drive measurable improvements in cost, quality, safety, and delivery.
- Develop and execute comprehensive continuous improvement roadmaps aligned with strategic business goals and global operations KPIs.
- Analyze manufacturing workflows, identify non-value-added activities, and implement Lean Manufacturing principles, including 5S, standard work, visual management, and pull systems.
- Apply Six Sigma methodologies (DMAIC, DFSS) and advanced statistical analysis (SPC, capability studies, regression modeling) to eliminate variation and improve process capability (Cp, Cpk).
- Collaborate with production, quality, and engineering teams to implement Corrective and Preventive Actions (CAPA) and process control plans in compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 14971 standards.
- Drive the implementation of standardized work instructions, poka-yoke (mistake-proofing) techniques, and visual factory systems to ensure consistency and repeatability.
- Utilize digital tools and platforms to support smart manufacturing initiatives, such as real-time data dashboards, IoT-enabled sensors, and MES integration.
- Facilitate training sessions and coaching for production staff, team leaders, and engineers on lean tools, quality improvement, and change management.
- Lead continuous improvement audits, track KPI trends, and develop monthly CI scorecards to report outcomes to leadership.
- Work with automation engineers and product development teams to support Design for Manufacturability (DFM) and New Product Introduction (NPI) programs with a CI focus.
Education
- Bachelor’s degree in Industrial Engineering, Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, or a related field is required.
- Master’s degree or additional certifications in Operations Management, Quality Engineering, or Lean Systems is preferred.
Required Skills and Experience
- Minimum 10 years of experience in continuous improvement, lean manufacturing, or process optimization within a regulated medical device, healthcare technology, or life sciences environment.
- Deep understanding of Lean Manufacturing, Six Sigma, Kaizen, 5S, VSM, and cellular manufacturing principles.
- Demonstrated expertise in leading complex CI projects using DMAIC, A3 problem solving, 8D, and PDCA frameworks.
- Proficiency in data analysis and statistical tools, including:
- Minitab
- Excel (advanced functions, pivot tables, macros)
- JMP
- Familiarity with FDA regulations (21 CFR Part 820), ISO 13485, and QSR (Quality System Regulation) requirements.
- Proficient with CAD platforms (e.g., SolidWorks, AutoCAD) and PLM systems for reviewing design-to-manufacture feedback.
- Experience working with ERP/MES systems such as SAP, Oracle, or Epicor in a production environment.
- Strong organizational, communication, and leadership skills with the ability to influence at all levels of the organization.
Preferred Qualifications
- Lean Six Sigma Green Belt or Black Belt Certification (ASQ or equivalent).
- Experience in implementing Industry 4.0 digital transformation initiatives in medical manufacturing.
- Exposure to automation, robotic assembly, or cleanroom process optimization.
- Prior involvement in design transfer, process validation (IQ/OQ/PQ), or statistical sampling plans for regulated production.
- Working knowledge of pFMEA, control plans, gauge R&R, and measurement system analysis (MSA).
- Background in biosensor, diagnostic equipment, or minimally invasive medical device manufacturing is a plus.
