Manufacturing Engineer Medical Device

DANISH INAMDAR

E: *********@*****.*** Ph:+1-682-***-****

Summary:

Results-driven Process/Manufacturing Engineer with extensive experience in medical device manufacturing process development and optimization. Proven expertise in:

• Process validation and compliance (IO/OQ/PQ, GMP, GDP, FDA, ISO)

• Troubleshooting and resolving production issues

• Automation integration and process improvement

• Risk analysis and mitigation (TMV, change analysis)

• Quality management systems (QMS, ERP, Six Sigma)

Skilled in:

• Process development (dispensing, tipping, printing)

• Root cause analysis and corrective actions

• Specification preparation and reporting

• Maintaining QMS and ensuring regulatory compliance

With a strong technical background and problem-solving skills, I drive excellence in medical device manufacturing through process optimization, quality improvement, and regulatory compliance.

DePuy Synthese Johnson and Johnson, Warsaw, IN May 2021 – Feb 2025

Manufacturing Engineer

• Optimized medical device manufacturing processes, collaborating with cross-functional teams to enhance quality and regulatory compliance.

• Developed and implemented IO/OQ/PQ procedures, change controls, and DQ documentation to ensure adherence to GMP and GDP guidelines.

• Managed process development initiatives using QMS and ERP software to streamline workflows and improve efficiency.

• Implemented TPLC, including TMV, change analysis, and risk analysis, to ensure regulatory compliance.

• Troubleshot and resolved production floor issues, enhancing manufacturing efficiency and product quality.

• Assisted in deviation investigation, problem resolution, and SOP correction to ensure compliance with cGMP and CFR regulations.

• Developed and maintained validation methodology to meet regulatory requirements and industry standards.

• Supported portfolio management across suppliers, improving supplier reliability and reducing manufacturing costs.

• Developed project timelines and tasks, building collaboration across cross-functional resources.

• Prioritized a portfolio of projects, allocating resources to meet business needs.

• Led three product transfers at suppliers, completing them in a timely manner.

• Utilized Windchill to manage change requests, routing inspection sheets, and routers (processed approximately 80 change requests).

• Experienced with Oracle Agile, including DCR and DRO routing.

• Proficient knowledge of process flows, control plans, and drawings.

• Created MPIs (Manufacturing Process Instructions).

• Experienced with B2B processes.

Foxconn, Fort Worth, TX Nov 2020 – May 2021

Industrial Engineer Intern

• Applied industrial engineering principles to improve process efficiency and productivity in a production environment.

• Analyzed and validated systems and equipment to identify areas for improvement.

• Collaborated with multidisciplinary teams to implement process changes and provided training to Production and QA departments.

• Developed and maintained documentation, including SOPs and rework instructions.

• Improved process efficiency by 25% through data-driven analysis and implementation of lean principles.

• Reduced production downtime by 25% through root cause analysis and corrective actions.

• Conducted root cause analysis for production failures, identifying key areas for improvement.

• Implemented corrective actions, resulting in a reduction of failures by 50%.

Precision Electors & Services Pvt Ltd, India Nov 2016 - Apr 2018

Mechanical Engineer

• Operated and maintained equipment to generate electricity, including boilers, turbines, gauges, controls, pumps, and fans.

• Performed routine cleaning, lubrication, and maintenance to prevent equipment failures and excessive wear.

• Monitored readings and observations to detect equipment problems, taking corrective action as needed.

• Adjusted controls to meet requested electrical power levels, starting and stopping generation equipment as required.

• Collaborated with cross-functional teams and external organizations to coordinate regional electrical generation.

Academic Projects

• Image Classification using CNN (Python, NumPy, TensorFlow)

- Developed a CNN model to classify images into 15 classes, achieving 93.7% accuracy.

- Implemented data preprocessing, normalization, and cross-entropy loss calculation.

• Multiple Linear Regression (SAS)

- Predicted university admission chances using CGPA, GRE score, TOEFL score, and university ratings.

- Provided insights for students to optimize their application process.

• Optimization and Prediction of Weld Bead Geometry (Laser Welding)

- Tested and optimized tensile and yield strength of dissimilar metal weld joints.

Skills

• Quality Management:

- Six Sigma Green and Black Belt certifications

- Lean, Ishikawa, 3P-Cummins, 5 Why analysis

• Software:

- MINITAB (Root cause analysis, Trend analysis)

- MS Excel, CAD Software (SOLIDWORKS, ANSYS, CREO, AUTO CAD)

- Microsoft Project, Windchill, Agile, Adaptiv, B2B, Planisware

• Programming:

- Python (TensorFlow, NumPy), SQL, MATLAB

Education

• Master of Industrial Engineering, University of Texas, Arlington

• Bachelor of Mechanical Engineering, University of Pune, India

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