Sumeet O. Email & Phone Number

Melbourne, Victoria, Australia

Melbourne, Australia

* Demonstrated leadership in managing cross functional teams comprising of Systems engineering, Firmware, Software, Hardware, Mechanical, HFE/ ID, Regulatory and Quality adhering to stage gate process and driving successful outcomes* Heavily engaged in leading business cases, putting proposals together along with planning and execution of diverse range of.

Melbourne, Australia

Key Achievements: * Secured next phase of product development: led initial consulting phase with the client to map strategies, requirements, concepts and high level project plan with best & worst case delivery timelines; recognized high level risks and identified mitigation strategies to increase confidence level; created project plan, work packages and.

Cleveland, OH

Project Development Engineer Key achievements:* Drove product innovation projects generating $4m+ revenue over 5 yrs: entrusted with several new innovative product launches, enhancements, line extensions; collaborated with stakeholders to define scope, budget, requirements; heavily engaged in design transfers & invivo/invitro lab studies; drove 5+ FDA.

• Responsibilities:
• Designed an innovative variation of a pre-existing product increasing potential company visibility by 15% in market competition
• Performed various CAD iterations and fabricated prototypes in conjunction with the internal prototype shop and outside suppliers
• Contributed in creation of development documentation consistent with FDA CFR 820.30, such as design input, risk analyses, verification & validation reports
• Demonstrated strong communication… Show more Responsibilities:
• Demonstrated strong communication skills during company presentations & while interacting with Sales reps, product managers to elicit product requirements

United States

• Responsibilities:
• Confidently interfaced with medical personnel, product managers & designers to elicit Product and Project inputs and requirements
• Proactively developed methods and protocols for product verification & validation testing of the IV pole, along with in-house testing and reviews for several products
• Promoted to team lead to mentor local and international teams for driving product engineering and platform launches supporting a $100 million+ product line

• Responsibilities:
• Conceptualized and designed an innovative instrument to facilitate insertion of hip implants in accordance to FDA regulations and company SOPs
• Consulted with surgeons, marketing, regulatory to facilitate proper design
• Coordinated and provided technical assistance in the production of prototypes
• Generated CAD models, drafted design and final drawings of products
• Performed detailed in-house testing and initiated surgical reviews of… Show more Responsibilities:

* Designed machine fixtures and gages using AutoCAD and PROE for manufacturing engineering components* Stress Tested the Fixtures and conducted verification and validation testing for machining accuracy and leakage testing* Collectively reduced machining time by 28 seconds per component in a production line of 3000 components per month leading to Total.

Project Leadership Certificate, Project Management

Ms, Mechanical Engineering

Research: Study of Fracture patterns on a human head impact using FEA • Created a 3D surface CAD model from CT scan data • Converted the.

Bachelor Of Engineering (Be), Mechanical Engineering

Activities and Societies: Vice President SAE- student chapter, ASHRAE- member,