Manufacturing Engineer

Job Description

Manufacturing Engineer – Medical Devices

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Job Description: Manufacturing Engineer – Medical Devices

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Position

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Job Title: Manufacturing Engineer

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Industry: Medical Devices / Healthcare Manufacturing

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Department: Engineering / Operations Excellence

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Location: [Location]

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Experience: 3–7 years

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Job Summary

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

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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.

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Key Responsibilities

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

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

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• Lean Six Sigma Green Belt or Black Belt certification.
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• Experience with ISO 13485 quality systems.
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• Familiarity with FDA 21 CFR Part 820 / applicable medical-device regulations .
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• Experience with Design of Experiments (DOE) and statistical process control (SPC).
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• Experience with automation, fixtures, tooling, or manufacturing equipment.
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• Knowledge of Minitab, JMP, Power BI, Excel , or similar analytical tools.
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• Experience supporting NPI, design transfer, process validation, and engineering change control .
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“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans. ”

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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 View phone number on ziprecruiter.com or send me email on View email address on ziprecruiter.com

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Regards

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Niraj kumar