Continuous Improvement Engineer

Continuous Improvement Engineer – Medical Devices

Job Description: Continuous Improvement Engineer – Medical Devices

Position

Job Title: Continuous Improvement Engineer

Industry: Medical Devices / Healthcare Manufacturing

Department: Engineering / Operations Excellence

Location: [Location]

Experience: 3–7 years

Job Summary

We are seeking a Continuous Improvement Engineer to drive process optimization, manufacturing efficiency, quality improvement, cost reduction, and operational excellence within a regulated medical device manufacturing environment.

The role will work closely with Manufacturing, Quality, R&D, Regulatory, Supply Chain, and Maintenance teams to identify improvement opportunities and implement sustainable solutions while maintaining compliance with applicable medical device regulations and quality-system requirements.

Key Responsibilities

• Identify and implement continuous improvement initiatives across manufacturing and engineering processes.
• Analyze production data, process performance, scrap, downtime, yield, and defects to identify improvement opportunities.
• Lead Lean Manufacturing, Six Sigma, Kaizen, 5S, and waste-reduction initiatives.
• Conduct root-cause analysis using tools such as 5 Why, Fishbone/Ishikawa, Pareto analysis, FMEA, and statistical analysis.
• Develop and optimize manufacturing processes to improve quality, productivity, yield, cycle time, and cost.
• Support process validation and engineering studies, including IQ/OQ/PQ, where applicable.
• Lead or support CAPA, nonconformance, deviation, and change-control activities related to manufacturing processes.
• Develop and maintain process documentation, work instructions, SOPs, process maps, and engineering specifications.
• Ensure process improvements are implemented in accordance with the company's Quality Management System (QMS).
• Support equipment qualification, process capability studies, and measurement-system analysis.
• Establish and monitor KPIs such as OEE, first-pass yield, scrap rate, cycle time, downtime, and process capability (Cp/Cpk).
• Collaborate with cross-functional teams to investigate recurring manufacturing and quality issues.
• Support the introduction of new products, equipment, technologies, and manufacturing processes.
• Evaluate automation opportunities and implement engineering solutions to improve process reliability and productivity.
• Prepare technical reports, project documentation, risk assessments, and management presentations.
• Participate in internal and external audits and provide appropriate engineering support.
• Ensure engineering activities comply with applicable medical device regulations, standards, and company procedures.

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Industrial Engineering, Manufacturing Engineering, Electrical Engineering, or a related field.
• 3–7 years of experience in medical device, pharmaceutical, healthcare, or other highly regulated manufacturing environments.
• Strong knowledge of Lean Manufacturing and Continuous Improvement methodologies.
• Experience with root-cause analysis, CAPA, FMEA, process capability, and statistical tools.
• Understanding of medical device quality systems and process validation.
• Strong analytical and problem-solving skills.
• Ability to work effectively with cross-functional teams.
• Good technical documentation and communication skills.

Preferred Qualifications

• Lean Six Sigma Green Belt or Black Belt certification.
• Experience with ISO 13485 quality systems.
• Familiarity with FDA 21 CFR Part 820 / applicable medical-device regulations.
• Experience with Design of Experiments (DOE) and statistical process control (SPC).
• Experience with automation, fixtures, tooling, or manufacturing equipment.
• Knowledge of Minitab, JMP, Power BI, Excel, or similar analytical tools.
• Experience supporting NPI, design transfer, process validation, and engineering change control.

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”

If you are inclined, I would be happy to set up some time to chat more about your background and career interests to see if there could be a possible match. Please feel free to call me on 732-806-7467 or send me email on nirajk@mindlance.com

Regards

Niraj kumar