Harish Kamath

About Harish Kamath

Senior Mechanical Engineer with 10+ years of experience delivering complex medical device and regulated hardware programs from concept through verification & validation, manufacturing, and lifecycle support. Proven track record of owning cross-functional workstreams, driving design and documentation readiness, resolving technical and supply-chain risks, and delivering projects on time within quality and regulatory constraints. Adept at coordinating engineering, manufacturing, quality, suppliers, and stakeholder - looking for a transition into Technical Project or Program Management roles.Work Profile: Project & Program Ownership• Owned end-to-end delivery of mechanical workstreams across NPI and lifecycle programs, from requirements and concept through validation, release, and manufacturing support.• Planned and executed engineering deliverables aligned to program milestones, ensuring readiness for V&V, regulatory submissions, MVP, and production ramps.• Managed multiple parallel projects with competing priorities while maintaining schedule, quality, and stakeholder alignment.• Led root cause analysis (RCA) and resolution of design, manufacturing, and quality issues impacting timelines or compliance.Cross-Functional Leadership• Acted as a primary coordination point between engineering, manufacturing, quality, suppliers, and regulatory teams.• Drove cross-functional design reviews, technical decision-making, and alignment across global teams.• Supported manufacturing setup and scale-up, working closely with operations and suppliers to enable smooth production transitions.Stakeholder & Supplier Management• Worked directly with suppliers and manufacturing partners to resolve quality issues, qualify alternate components, and implement design changes.• Led DFMA discussions to balance performance, cost, manufacturability, and timeline constraints.• Communicated technical status, risks, and mitigation plans clearly to stakeholders.Team Enablement & Leadership• Mentored junior engineers, interns, and cross-functional contributors, enabling independent task ownership.• Supported knowledge sharing through design reviews, technical sessions, and problem-solving forums.• Built a reputation for reliable execution, accountability, and follow-through.Core Competencies: Technical Project Ownership | Global cross functional and supplier co-ordination | Mechanical Systems & Subsystem Design | Engineering Specifications & Requirements Management | ISO 13485 | IEC 60601 | Engineering change management

Experience

1. Senior Mechanical Engineer

   GE医疗

   Jan 2024 — Present · Bengaluru, IN

   Served as Mechanical technical owner across multiple projects delivering on Maternal Fetal Monitoring accessories, maintaining momentum across overlapping timelines.• Drove on-time milestone delivery (FDR2/M2, MVP, FDR3/M3) by proactively managing risks, resolving quality issues, and accelerating documentation closures.• Demonstrated lean execution by rapidly addressing manufacturing and quality issues (Labeling, Engineering BOM, Plastics), preventing schedule impact.• Delivered design improvements enhancing safety, reliability, and manufacturability, including ULS/TOCO knobs, bottom case redesigns, NICU heater door retention mechanisms.• Drove ATD development and closure (Heat Engine), improving patient safety and accelerating VCP outcomes with potential to save upto $1M per year.• Led manufacturing readiness activities, including fixture setup, laser-printed label qualification, and supplier coordination to support pre-MVP and MVP builds.• Led cross-functional collaboration with PEACE, product management, clinical teams, suppliers, and manufacturing to align design, usability, and supply-chain readiness for future ready projects.• Mentored and coached EEDPs and interns, enabling independent ownership of design tasks and fostering a learning culture.• Championed innovation and future readiness, proposing multiple IP concepts and supporting next-generation wireless and miniaturized product strategies.• Built strong supplier partnerships, ensuring timely issue resolution and part delivery under aggressive timelines.• Delivered rapid concept development and prototyping for next-generation products strengthening future product pipelines.• Strong working knowledge of ISO 13485, IEC 60601, and ISO 14971; Reliability Yellow Belt certified to enhance future technical capabilities.

Education

• Manipal Institute of Technology

  Master of Technology - MTech, Computer Aided Analysis and Design

  2017 — 2019

• BMS College of Engineering

  Bachelor of Engineering (BE), Mechanical Engineering

  2009 — 2013

• National College Basavangudi

  Pre-University Course, Science (PCME)

  2007 — 2009

Skills

• Catia
• Autocad
• Nx 9.0
• Solidworks
• Windows
• Powerpoint
• Microsoft Excel
• C++
• Nc Simul
• Pro Engineer
• Engineering
• Fixture Design
• Ansys
• Teamwork
• Vericut
• Microsoft Office
• C
• Programming
• Matlab
• Microsoft Word
• Nc Programming
• Catia(Cam)
• Edge - Cam