Manufacturing Engineer Medical Device

Kalhan Kampasi

Boston, MA ***** 734-***-**** *******.*@*****.***.*** LinkedIn

QUALIFICATIONS SUMMARY

Manufacturing engineer with experience working in the medical device industry. Significant exposure to Supplier Development, Device Assembly, Process Validation, and Data Analysis. Strong operations professional with a master’s degree in Industrial Engineering and certificate in Supply Chain Engineering Management. PROVEN EXPERTISE

Process Validation – IQ, OQ, PQ

Supplier Development

R&D for Manufacturability

Quality Assurance

Data Analysis – Minitab, JMP, R

Manufacturing Operations

Root Cause Analysis

Lean Six Sigma Green Belt

PROFESSIONAL EXPERIENCE

INSULET CORPORATION (Acton, MA)

$5 billion global manufacturer of Omnipod, tubeless insulin pump for diabetes patients Manufacturing Engineer, Global Manufacturing, January 2019 to Present Lead validation and qualification of two sub-assemblies of Omnipod at Insulet’s first manufacturing facility in USA. Root cause and troubleshoot discrepant sub-assemblies and devices. Outcomes:

Lead manufacturing operations and documentation processes for two fully automated sub-assemblies.

Perform process capability studies (Ppk, Cpk) on critical sub-assembly stations.

Design DOEs and Gage R&R studies to improve manufacturing processes and measurement methods.

Work with Quality Assurance to conduct FAIs, in-process inspections and NCMR activities. Manufacturing Engineer Co-op, Supplier Development, January 2018 to August 2018 Supported supplier qualification and development by evaluating metal and plastic suppliers using R&D lab tools and statistical data analysis methods. Outcomes:

Saved $80,000 inventory by root causing and troubleshooting component functional failure.

Inspected supplier quality using test fixtures like Instron force fixture, pneumatic fixtures and microscopes.

Created work instructions, test procedures and provided training to new employees on test methods.

Maintained compliance with medical device quality system by writing ECOs and BOMs. SUN PHARMACEUTICAL INDUSTRIES (Jammu, JK, India)

Largest pharma company in India that manufactures and sells pharmaceutical formulations Manufacturing Engineer Intern, Maintenance and Utility, November 2015 to April 2016

Handled maintenance and utility operations for drug manufacturing facility.

Improved HVAC system by performing tests and taking corrective actions. EDUCATION

MS in Industrial Engineering, December 2018 — NORTHEASTERN UNIVERSITY (Boston, MA) Highlights: Lean Manufacturing, Supply Chain Engineering, Data Mining, Operations Research, Financial Management, Logistics, Warehousing and Scheduling, Statistical Methods in Engineering Supply Chain Engineering Certificate, December 2018 — NORTHEASTERN UNIVERSITY (Boston, MA) Bachelor in Instrumentation Engineering, June 2015 — UNIVERSITY OF MUMBAI (Mumbai, India)

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