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 projects to high profile local and international clients* Expert at creating dashboards, status reports for stakeholders, senior… Show more * 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 projects to high profile local and international clients* Expert at creating dashboards, status reports for stakeholders, senior management and clients about work packages, KPIs, performance, resourcing, utilisation and budget * Spearheaded more than 7+ projects ranging from a team size of 5 upto 15 to work closely with clients in the Medical device space ( Class II, Class III active implantable, Combination drug device) space to deliver optimal solutions under tight deadlines* Successfully delivered several projects as per time, budget and technical expectations * Developed solid understanding of ISO 13485 processes along with FDA 21 CFR 820 and EU IVDR regulations Show less

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 detailed mapping of deliverables; outlined commercial marketing strategy to map Product vision; successfully secured buy-in from client… Show more 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 detailed mapping of deliverables; outlined commercial marketing strategy to map Product vision; successfully secured buy-in from client for next phase* Used Lean principles to deliver microfluidic project against aggressive timelines & budget: challenged with international client’s requirements for microfluidic solution to integrate existing sensor; identified critical success factors; led project end-to-end with lean work packages and resource management; escalated risks to leadership for key decisions; drove leads to develop robust test strategy and plan; wowed client by successful delivery of project by functional and additional features Show less

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 510(k) submissions; conducted vigorous testing & led device/predicate device comparisons; liaised… Show more 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 510(k) submissions; conducted vigorous testing & led device/predicate device comparisons; liaised with legal counsel and attorneys to scope IP landscape; delivered multiple projects leading to significant revenue * Resolved field customer complaints saving reject costs: tackled with multiple field customer complaints for existing products; drove team through root cause analysis activities to identify cause & optimal solutions; aligned product risk profile based on complaints; reduced complaints by 45% for 2 high volume products in 9 months Show less

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: • 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 skills during company presentations & while interacting with Sales reps, product managers to elicit product requirements• Participated in approval of design reviews, deviations and engineering changes Show less

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: • 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 the instrument in support of product design and sales support • Developed detailed technical documentation, and presented technical presentations for internal as well as external customers Show less

* 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 Annual savings of $35,000* Executed Process Planning for numerous aluminum components * Managed supplier… Show more * 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 Annual savings of $35,000* Executed Process Planning for numerous aluminum components * Managed supplier development for an entirely new project* Ensured that Projects maintain momentum and hit timelines in an effective manner* Worked on creating unique engineering solutions to meet Customer's unmet needs* Integrate inputs from technical, manufacturing, and marketing to prepare part drawings, tolerance stack-up studies and support documentation Show less

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.

Bachelor Of Engineering (Be), Mechanical Engineering

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