Sales engineer Resume

SUMMARY

Trained Biomedical Engineer, worked successfully on performing product verification and validation performing clinical performance summary, similar device analysis and functional relationship analysis and performing risk management activities in various multinational and start - up companies across Confidential
Performed IQ/OQ/PQ on certain laboratory equipments such as evaporators, mask aligners etc.
Worked successfully on performing product verification and validation performing clinical performance summary, similar device analysis and functional relationship analysis and performing risk management activities
Expert in generating Design and Process Failure Mode and Effect Analysis (FMEA), and other risk management files and documents
Experienced in Product/Equipment Design, Process control and Continuous Quality improvements
Working knowledge in equipment and Process validation in compliance with FDA standards
Hands on experience in Design History Files(DHF)
Proficient in Statistical Process Control (SPC) methodologies and best practices.
Knowledge about the FDA regulations like 21 CFR part 820 and ISO 14971, 13485
Proficient in employing Lean & Six Sigma tools, process flow techniques, and troubleshooting & resolving technical problems
Working knowledge of Geometric Dimensioning and Tolerances (GD&T)

PROFESSIONAL EXPERIENCE

Confidential

Sales engineer

Responsibilities:

Initiated online platform for sales and distribution of fast consumables medical devices for mid-segment hospitals and corporate healthcare institutions
Researched and interacted with the market to help define long term direction for product roadmap
Execution of marketing and communication strategy

Confidential

Product Development Engineer

Responsibilities:

Gathered user needs for CMC Malis generator (a product line of a newly acquired company) and completed the updated Design Control Traceability Matrix (DCTM)
Formulated a statistical algorithm for effective execution of technology and manufacturing line transfer
Completed label requirements and generated Instructions for Use (IFU) and package inserts for Malis generator and probe

Confidential

Manufacturing Engineer

Responsibilities:

Validating processes (cleaning and validation) and production of Zimmer CSTi coated products
Performing and validating tensile test reports of different variety of product samples
Generating IQ/OQ/PQ of installed testing machines

Confidential

Quality Engineer

Responsibilities:

Handling complaints of all range of products for audit readiness program in accordance with FDA protocols
Creating and maintain risk management files (RMF) of hips, knee and trauma products

Confidential

Development Engineer

Responsibilities:

Performing Functional Relationship Analysis (FRA), Similar Device Analysis (SDA), Clinical Performance Summary (CPS) on legacy and acquired products
Generating DHF on existing products in accordance with the FDA protocols
Validating and verifying product design prints utilizing drafting standard, GD&T and analytical mechanics concepts
Generating Quality System Reviews (QSR) and Design Control Traceability Matrix (DCTM) on certain range of implants

Confidential

Product Development and Systems Engineer

Responsibilities:

Developed Design and Use Misuse FMEA by leading multi-functional teams for Renal Products used to treat Continuous Ambulatory Peritoneal Dialysis
Documented Functional Requirement Documents (FRDs), Process Flows, Test Cases, and Use Cases according to the Rational Unified Process (RUP) methodology
Formulated database using IBM Rationale DOORS

Confidential

Manufacturing Engineer

Responsibilities:

Designed pair of shadow masks utilizing AutoCAD (Solid Works), fabricated thermopile utilizing Physical Vapor Deposition PVD and assembled biosensor required for thermoelectric sequencing of DNA
Performed layer-by-layer self-assembly and injection molding to fabricate thermoelectric microfluidic system for genetic mutation assay
Devised a new method to improve the quality and quantity of thermopile production which entailed integration of grooves to an aluminum template yielding in 300 % increase in thermopile production