Nihar M.

Nihar M. Email and Phone Number

Manufacturing Leader passionate about launching and scaling innovative products @ Jupiter Endovascular
Nihar M.'s Location
San Francisco Bay Area, United States, United States
About Nihar M.

Experienced manufacturing operations leader passionate about leading commercialization and scaling of innovative products. Spent a decade learning/executing best in-class operational strategies at reputed organizations such as NUMMI, Applied Materials, Stryker & Medtronic. Spent last 6+ years leading commercialization and scaling of disruptive products such as wearables (Fitbit- Acquired by Google) and robotically-driven, flexible Endo/Utersoscopes (Auris- Acquired by Johnson & Johnson).Experienced scaling to variety of volumes (30 per week to 30,000+ per week) with all FATP engagement models such as all FATP in-house, hybrid, CM/OEM/ODM. Experienced selecting CM/ODM-JDM/Component Manufacturers and driving CM/Component Supplier performance. Experienced with Gross Margin/DFM driven Design/ Component Sourcing/Testing strategy definition and execution. Specialties: Lean Operational Excellence (Pilot and Production Line Set-ups, SQPD+ Line Management Tools, Time Studies, Line Balancing, Kaizen/CIP, Standard Work/Routing) , Process Excellence (DFx, DOE/Characterization, Stats, GD&T, Failure Analysis), Product Launch Management (Project Management, Manufacturing Transfers, BoM Management, Configuration Management, Product Structure Management, Change Order Management, S&OP for Pilot Lines), Compliance & Risk Management (FMEA, Design Controls, Validation, NC/CAPA), Finance (Cost of Ownership, Cost of Quality, Activity Based Costing), Supply Chain (Supply Chain Readiness, Sourcing/ Mfg/Test Strategy, S&OP, Supplier Selection, Make vs Buy, Should Costing)

Nihar M.'s Current Company Details
Jupiter Endovascular

Jupiter Endovascular

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Manufacturing Leader passionate about launching and scaling innovative products
Nihar M. Work Experience Details
  • Jupiter Endovascular
    Director Of Manufacturing
    Jupiter Endovascular Nov 2023 - Present
    Menlo Park, California, Us
    Manufacturing Lead for Neptune Medical CV Division now known as Jupiter Endovascular
  • Talis Biomedical Corporation
    Director Of Manufacturing Engineering, Ivd
    Talis Biomedical Corporation Feb 2022 - Nov 2023
    Redwood City, Ca, Us
    • Planned and executed implementation of stalled design changes resulting in improved manufacturability and reliability of Talis One Instrument• Led Engineering builds at novice CM increasing throughput from 0 to 7 instrument a week Instrument Mfg delivered 250+ devices in 2022 leading to V&V execution• Implemented structured problem-solving resulting yield stabilization at > 75%• Implemented weekly CM report card based on Safety, Quality, Delivery and Efficiency resulting in throughput and yield stabilization• Led New CM selection with Supply Chain and Quality resulting in identification of long term mfg CM partner better aligned with business needs
  • Auris Health, Inc
    Sr Manager, Mfg Engineering, Npi, Instruments, Monarch
    Auris Health, Inc Jul 2021 - Mar 2022
    Redwood City, California, Us
    • Promoted to Sr Manager with expanded oversight of Component Engineering, Strategic Gross Margin Improvement focused next gen. of Bronchoscopy & Urology products, & JNJ-Auris Integration Projects including QMSo Integrated JNJ NPI Best practices like should-costing, NUDS assessments, make vs buy, on next generation Monarch Consumables resulting in a successful Phase 0 criteria of >60% GM target deemed achievableo Led margin improvement scoping exercise for Re-usable Bronchoscopes with external consultants resulting in identification of supplemental paths to achieve profitability in-addition to NPI efforts to qualify more uses per device
  • Auris Health, Inc
    Manager, Mfg Engineering, Npi, Instruments, Monarch
    Auris Health, Inc Aug 2020 - Jul 2021
    Redwood City, California, Us
    • Carved out NPI Mfg Engineering Function and established Manufacturing as Service to R&D and Production with expertise in Dfx, process development, assembly fixture development, Industrial engineering/Build Management, and Design Transfers• Performed SWOT on NPI Team against success factors. Crafted a resource plan based on teams’ strengths, weaknesses, opportunities, and threats. Hired 9 Engineers and Promoted 3 Engineers to grow the team to 15 engineers in < 1 Year. Expanded 8 people pilot line into 30 people pilot line including 4 promotions. • Expanded scope of the team to focus on all new products from Phase 0 to Phase 6 including accessories managed through CM’s. • Achieved ~90% retention rate since taking over the team in Fall 2020• NPI Team delivered ~1600-2000 devices over last 2 years resulting in commercialization of Robotically driven Bronchoscope 2.0 on Monarch 2.0 Platform and 510K submissions for other indications• Sponsored Daily Line Management tool (Safety, Quality, Delivery, Productivity) deployment & GEMBA walks. This resulted in improved communication (Up, Down, & Lateral) & prioritization of COGS/Scalability improvements based on ROI. These improvements resulted in robust design transfer & Process simulation modelling to enable ramp planning• Sponsored Agile Project Management Focused JIRA communication Board for Managing Design Transfer resulting in improved communication (Up, Down, & Lateral), prioritization, resource utilization, and scheduling on NPD programs.
  • Auris Health, Inc
    Staff Manufacturing Engineer
    Auris Health, Inc Jun 2018 - Aug 2020
    Redwood City, California, Us
    •Led operations team on 2nd Gen, Single-Use & Re-usable robotically driven Endoscope (Flexible Catheters with Optics) from concept to volume mfg. enabling Auris to scale manufacturing to double annual case load support while breaking-even on COGS• Established a non-existent NPD build process including planning, procurement, finance, and R&D inspired from traditional S&OP process. Supplemented planning process with readiness checklists (Clear to Build) and weekly check-in points for cross-functional team for smoother pilot production planning• Converted 2 station Pilot line to 10 station pilot line capable with 20/week yielded throughput• Led early pre-design Freeze Builds to drive DFM, Process Development, & DV Readiness resulting in ability to complete DV&V builds in predicted timeframes• Established strong failure analysis approach to root-cause early and identify design or process mitigations resulting in 20-30% RTY yield improvements from development to launch• Led Design Control Deliverables such as PFMEA, TMV, Process Characterization, Optimization, & Validation concurrently with DV&V builds to ramp-up to 50/week throughput post PPQ resulting on on-time shipment of commercial use product•Led 1st Gen Endoscope Commercial Mfg expansion strategy development and deployment including future outsourcing opportunities resulting in 4-fold increase in weekly throughput•Root-caused & eliminated EM sensor related Out of Box failures on 1st Gen Robotically Driven Endoscope resulting in product complaint rate reduction from 8% to 5%. Further reduced EM sensing yield loss failures and in-house component rework resulting in ~150K in annual savings
  • Fitbit (Now Part Of Google)
    Manufacturing Engineer V/Staff Manufacturing Engineer (Advanced Operations/New Products)
    Fitbit (Now Part Of Google) Sep 2017 - May 2018
    San Francisco, California, Us
    -Led business process development to help Fitbit transform from a successful start-up to a more organized and lean business-Implemented process flow for selection of ODM or JDM operations model for future Programs-Implemented Production Component release, assembly fixture, and line validation process to improve coordination and efficiency among NPI, cross-functional teams
  • Fitbit (Now Part Of Google)
    Manufacturing Engineer Iv/ Sr Mfg Engineer (Advanced Ops/Npi)
    Fitbit (Now Part Of Google) Mar 2016 - Sep 2017
    San Francisco, California, Us
    -Led manufacturing team from concept to volume phases on Fitbit Versa, Flyers, and Alta HR. Led Ionic Design Transfer into production.-Led DFx reviews from Concept Alignment to EVT builds resulting in $700k in CAPEX and $0.40 per unit MVA savings, combined on all three products▪ Drove factory readiness for Versa, Flyers, and AltaHR product line for DVT, PVT, and MP builds. All 3 products commercialized with >90% Yield, >420 UPH, > 3 lines, > 40% GM, and on an unprecedented record schedule resulting in major revenue recognition of combined $ 300-400 Million in the launch quarters.▪ Led EVT, DVT, PVT, and MP assembly line and fixture qualification and validation for Fitbit Alta HR, Flyers, Ionic , and Versa at CM partners in China-Operations Lead/SME on selection of JDM partner for Fitbit Flyers
  • Medtronic Vascular
    Manufacturing Engineer Iii (New Products/Advanced Operations)
    Medtronic Vascular Oct 2012 - Mar 2016
    Minneapolis, Mn, Us
    ● Led selection of wire forming technology based on cost of ownership (COO) and qualitative analysis resulting in consensus and intelligent, long term selection with lowest financial impact to business▪ Integrated activity based costing (ABC) and COO in conjunction with lean based Medtronic Operating Strategy (MOS) resulting in identification of need to track and analyze equipment speed, yield, space, utility consumption, attended labor time, and maintenance costs● Proposed optimized cellular DFS operations layout to meet volume demand using discrete event simulation (DES) software resulting in 30% lower labor and 50% less space than line layout● Promoted propagation of DES software across Medtronic in New Product Operations by co-authoring a paper at S & T technology conference (internal Medtronic event)● Led development of more space efficient, automated, and one piece flow equipment for Wrapping, Post-Wrap Clean and Drilling using statistical analysis tools such as Design of Experiment which will result in 30% space reduction, 90% reduction in batch size, and 25% reduction in attended labor time● Co-led establishment of Advanced Manufacturing Engineer discussion forum to share knowledge, ideas, and benchmark approaches to new product operations● Actively identifying and proposing solutions for strategic gaps such as lack of comprehensive equipment development and sourcing strategy● Championing clarity in lean strategy with clearly stated long term and short term benefits and direct cause-effect relationship● Led the development of the Advanced Manufacturing Engineer internal share-point site to further enhance communication among Engineer’s from all Cardiovascular group
  • Stryker
    Manufacturing Engineer Ii, (New Products/Advanced Operations)
    Stryker May 2011 - Oct 2012
    Kalamazoo, Mi, Us
    ● Assumed Advanced Sourcing Engineer role in addition to Advanced Manufacturing Engineering role. As ASE, led following:▪ Led component make/buy decision based on comprehensive cost and strategic analysis▪ Championed and implemented process validation and a sampling plan at supplier for critical component using Cost of Quality to justify higher upfront investment● Led decision making on sourcing of T-Pumps from a Gaymar Acquisition on comprehensive financial (income, cash flow, and balance sheet) and qualitative analysis resulting in decision to award business to International Contract Manufacturer at US based facility● Led transfer of Stryker Glide System from a small domestic CM to Flextronics/Avail Medical in Mexico● Integrated equipment/tooling/fixture calibration and PM scheduling and maintenance in JD Edwards resulting in improved compliance to production and process controls● As Training lead for the mfg. team set up customized curriculums for different mfg. engineering levels, functions, and special situations
  • Stryker
    Manufacturing Engineer I (Advanced Operations/New Products)
    Stryker May 2010 - May 2011
    Kalamazoo, Mi, Us
    ● Manufacturing Core Team Lead on Prime X product development from Concept through Volume Mfg.● Led PFMEA and participated as core team lead in Product Risk Assessment and DFMEA● Defined manufacturing and sourcing strategy for the Trauma Stretcher product● Led DFx reviews with process experts to ensure product cost ($751) was below set target ($794) resulting in at least a 3% overall gross margin improvement for every stretcher sold● Created and managed Capital Expenditure for the New Trauma Stretcher project (600K) coming well under Capital Expenditure requested for the project (657K)● Planned, organized, and executed seamless builds with cross functional team resulting in achievement of major project milestones▪ Set up assembly lines with most efficient space usage resulting lowering burden to the manufacturing cost▪ Balanced lines to create a pull system to prevent in-process inventory build-up
  • Applied Materials
    Manufacturing Engineer I (New Products/Advanced Operations)
    Applied Materials Jul 2007 - May 2010
    Santa Clara, Ca, Us
    ● Defined manufacturing, sourcing, and test strategy in alignment with overall operations strategy of Modular Testing/Merge in Transit/Integrate-to-Order for three different new products in different product lines● Executed operations strategy for DPN and ALD chambers resulting in at or below cost, below capital budget, and on schedule commercialization▪ Determined root cause for 35 Non-Conformances (NC) that occurred during assembly/ field retrofit of ALD and DPN chambers. Lead cross-functional team members to implement most feasible design/solution leading to closure of all and zero repeat NC’s▪ Defined 14 Retrofit/ Evaluation tool Bill of Materials (BoM) for Beta evaluation shipments with no BoM NC▪ Lead the release of a customer Specific ALD chamber with 20 ECO's in less than a month and simultaneously leading the build activities on Pilot Line● Defined the Manufacturing BoM's and organized the product structure on all supported NPI products● Sustained Low Pressure Chemical Vapor Deposition (LPCVD), DPN, RTP and Metal Organic Chemical Vapor Deposition (MOCVD) product lines▪ Launched, released, approved, and implemented ECO’s in < 21 days through Change Control Board process (CCB)▪ Reduced a 3 month, 33 ECO back log for the Rapid Thermal Anneal (RTP) product line within a month, two months ahead of schedule resulting in critical revenue recognition
  • Nummi
    Tps Co-Op
    Nummi Jan 2007 - Jul 2007
    Fremont, California, Us
    Performed root cause analysis and solved problems by participating in Jishukens (Problem Solving Circles) in Truck Sub Assembly, Truck Paint, and Q.C.E.Prepared and presented A-3 reports on the findings. Participated and Co-lead TPS fundamentals and Standardized Work Training classes for manufacturing personnel of all levels. Worked in Truck Sub Assembly, Body Shop Sub Assembly, Truck Paint, & Plastics. Participated in 5S activity. Performed time studies of car assembly, plastic department, and final inspection of GM Vibe. Improved, efficiency by eliminating “muda” (non-value adding) of motion.
  • Microgenics
    Manufacturing Engineer Intern
    Microgenics Oct 2006 - Nov 2006
    Us
    Designed components for automated bottle filling machine using Solid works. Validated and implemented a label printer on the automated filling line.Responsible for developing preventive maintenance procedures for a variety of manufacturing equipment

Nihar M. Skills

Lean Manufacturing Manufacturing Engineering Technical Training Root Cause Analysis Failure Mode And Effects Analysis Pfmea Microsoft Powerpoint 5s Fmea Cad Geometric Dimensioning And Tolerancing Validation Engineering Medical Devices Gd&t Toyota Production System Microsoft Excel Design For Manufacturing Machining Cross Functional Team Leadership Manufacturing Design Of Experiments Solidworks Product Development Npi Management Spc R&d

Nihar M. Education Details

  • San José State University
    San José State University
    Mechanical Engineering
  • Gujarat University
    Gujarat University
    Mechanical Engineering
  • Mk Higher Secondary School
    Mk Higher Secondary School
    Science

Frequently Asked Questions about Nihar M.

What company does Nihar M. work for?

Nihar M. works for Jupiter Endovascular

What is Nihar M.'s role at the current company?

Nihar M.'s current role is Manufacturing Leader passionate about launching and scaling innovative products.

What schools did Nihar M. attend?

Nihar M. attended San José State University, Gujarat University, Mk Higher Secondary School.

What skills is Nihar M. known for?

Nihar M. has skills like Lean Manufacturing, Manufacturing Engineering, Technical Training, Root Cause Analysis, Failure Mode And Effects Analysis, Pfmea, Microsoft Powerpoint, 5s, Fmea, Cad, Geometric Dimensioning And Tolerancing, Validation.

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