KoalaT.ai

As a Freelance Project Manager, I specialize in regulatory compliance and quality management services for the medical device industry. My goal is to ensure that medical device companies achieve full compliance with FDA, ISO, and EU MDR regulations, while optimizing quality systems and operational efficiency.

Services Provided:

Regulatory Compliance Audits: Conduct comprehensive audits to evaluate and ensure compliance with FDA, ISO 13485:2016, and other relevant regulations.

Supplier Quality Management: Implement strategies to improve supplier performance, reduce costs, and enhance quality across the supply chain.

AI-Driven Compliance Solutions: Leverage AI technology to streamline compliance processes and provide data-driven insights for decision-making.

Process Optimization: Manage projects that optimize processes to improve efficiency and compliance readiness.

Flexible Engagement Options:
-Hourly Ad Hoc
-Short-Term Projects
-Long-Term Contractual Agreements (Remote or Onsite)

Industries Served:
-Medical Devices
-Pharmaceuticals
-In-Vitro Diagnostics

Specialized Audit Services:
FDA Mock Inspections
CAPA Management
ISO 13485:2016 Compliance
Supplier Audits
Quality System Audits (21 CFR Parts 820)
Multi-Country Registration & Approvals (US 510K, EU CE Mark)

Key Achievements:
Successfully reduced audit findings by up to 95% for multiple clients.
Developed and implemented AI-driven tools to optimize compliance processes, resulting in significant efficiency gains.

Contact Information:
If your organization needs expert guidance to navigate regulatory challenges and ensure quality compliance, feel free to connect with me here on LinkedIn or via email Neel@KoalaT.ai

Fractional Project Manager

Medtronic

• Led Audit Readiness program for Global Field Corrective Action (recalls) and Product Hold Order across four portfolios, enhancing audit preparation and execution.
• Collaborated with cross-functional teams to implement effective audit strategies, significantly reducing findings and ensuring compliance.

Enterprise Audit Readiness Program Manager

Endologix LLC

• Managed Supplier Change program to maintain supply chain continuity and oversee product lifecycle management
• Ensured design review, risk assessment, and control establishment in cross-functional teams
• Drove the completion of over 70+ supplier change evaluations and achieved EU MDR compliance
• Acted as front room SME during FDA, NSAI, ANVISA, and GMED audits and leveraged cross-functional SMEs in the backroom

Sr. Supplier Quality Engineer 

• Led cross-functional teams to complete Quality Impact Assessment, Component Qualification, and Supplier development
• Achieved design improvements, supplier changes, quality objectives, and supplier selection
• Led non-conformance investigations, and supported continuous improvement initiatives

Sr. Supplier Quality Engineer (Neurovascular)

Phillips-Medisize

• Implemented strategies for driving product quality and continuous improvement for Class I-III Medical Devices
• Developed CAPA documentation in partnership with suppliers, customers, and PMCM for effective root cause analysis and corrective action

Lead Supplier Quality Engineer

Alcon

•	Primary supplier quality contact for surgical consoles, PCB, and consumable product lines
•	Responsible project owner of supplier data analysis utilized in implementing updated Approved Supplier List (ASL) and retirement of suppliers in Supplier Review
•	Responsible for supplier’s qualification, assessment, review, and approval. Supplier surveys, Supplier Quality Risk Assessments, supplier certifications, first time buy approvals and Quality Agreements 
•	Provided Component Risk Assessments and verification by analysis for ultimate drawing updates in Engineering Change Notifications (ECN)
•	Provided assessment of dock to stock inspection data analysis of components 
•	Created and approved closure of quality notifications in SAP, gathered data regarding the supplier and the current inventory needing containment activities to ensure the production schedule could be met
•	Communicated Receiving Inspection & WIP defects to suppliers through the use of Supplier Action Request (SAR)/CAPA system
•	Completed training for basic auditor and (desktop) virtual auditing on Quality Management Systems to ensure conformance (ISO 9001 and 13485, CFR 21)
•	Responsible for project analyzing documentation, data, inspection, and drawings updates for safety critical components and compliance 
•	Resolved quality issues of capability, tolerance, and material related issues
•	Collaborated with suppliers, vendors, and teams of engineers to troubleshoot reoccurring nonconformances and safety critical issues 
•	Capable of managing large data and sharing statistical interpretation 
•	Experience with medical device production, process improvement and project management
•	Experience communicating with outside vendors and suppliers on cost contracts, technical drawings, production processes, and project needs
•	High understanding of team’s manufacturing and documentation process

Supplier Quality Engineer 

Chegg Inc.

• Assisted students with test taking tips and strategies. 
• Multitasked and prioritized independent work. 
• Tracked and analyzed student progress. 
• Communicated effectively with parents and staff.
• Helped students build knowledge on difficult topics such as preparing for SAT. SAT subject tests, and ACT as well as physics, chemistry, biology, biochemistry, and engineering.

Chegg Tutor

Torticollar (Sr. Design Project)

Slashed production costs from $2000 to $100 per unit.
Negotiated contracts with outside mass manufacturing suppliers.
Managed production, process improvement, prototyping, benchmarking, bench testing, 3-D printing, business team operation, as well as generated investor reports and presentations.
Investigated patent approval with medical patent lawyer consultation.

Quality Engineer / Research & Development		

University of California, Riverside Pediatric Rehabilitation Technology Lab

Using logistical models, conducted data analysis, obtaining measurements, performing study design and research methodology, as well as research-related activities, and initiating programming activities using MATLAB coding for examination of novel neuro-rehabilitation environments that aim to improve physical function and promote the development of children with motor disorders.

Research Assistant

Riverside Healthcare

Managed front desk, assisting patients with checking in, operating kiosks, and providing directions to various places within the facility. Also assisted with discharge and the transport of patients through the hospital and to their vehicles.

Volunteer

Program Manager | Supplier Management, Medical Device Auditor, AI

I help medical device startups and SMBs in the Midwest conquer FDA, ISO 13485, and EU MDR audits with confidence. 

I'm a certified Quality professional with 3+ years of experience building and optimizing compliant, efficient systems, specializing in:

Audit Readiness: Developing and implementing robust programs that streamline preparation and minimize findings.

Supplier Quality Management: Ensuring your suppliers meet the highest standards, reducing risk and improving your supply chain.

AI-Powered Solutions: Leveraging cutting-edge technology to enhance efficiency, provide data-driven insights, and create a proactive approach to compliance.

I have a proven track record of successfully leading projects that transform quality systems and deliver tangible results. 

For example, at a global medical device company, I spearheaded an enterprise-wide audit readiness program that reduced audit findings by over 95% while simultaneously supporting a remote Warning Letter re-inspection, ensuring a smooth and efficient process that led to the Warning Letter being lifted.

Building strong supplier relationships and navigating the complex regulatory landscape are also key areas where I excel. My data-driven approach, combined with a deep understanding of AI applications, allows me to solve complex problems and deliver solutions that directly impact your bottom line.

I hold multiple certifications in quality auditing (Certified Medical Device Auditor, Supplier Quality Professional, and Quality Auditor) and have a strong background in Biomedical Engineering (B.S.) and Technology & Innovation Management (M.S.). I've completed specialized coursework in AI in Healthcare & Biotech and Pharma from MIT Sloan School of Business, further enhancing my expertise in leveraging AI to solve real-world challenges in the medical device industry.

As a lifelong learner, I am dedicated to staying current with the latest trends, tools, and technologies, and sharing that knowledge with others. In my spare time, I enjoy testing AI devices and models, riding One-Wheel, home improvement, and producing electronic music.

If your medical device company needs a seasoned project manager who can step in and drive your critical projects to success, let’s connect.

I’m currently offering a complimentary discovery call to discuss how we can work together to streamline your projects, ensure compliance, and bring your life-saving technologies to market more efficiently.

Neelank Tiwari, MS, PMP

AcousticSelling

Our Rocket SaaS methodology propels B2B SaaS companies to $50 million ARR by delivering clarity and predictability from the chaos of early GTM.  Our logical, step-by-step framework starts with vetting your GTM strategy and ends with rapid delivery of easy-to-use and easy-to-maintain customizations in UI/UX, Process & Workflow, and Data & Analytics.

We're a small and deep team with the business acumen, technical skills, and library of solved Salesforce use cases ready to be tailored and deployed into your organization.  We'll also connect your CRM to core tech stack platforms such as Marketing Automation, Sales Engagement, Data Enrichment, Conversation Intelligence, Document Management, and more.

Managing Director

McKinsey & Company

Assisting the Fuel by McKinsey team with sales and sales technology products, services, and client-facing engagements.  We help pre-IPO companies, investors, and corporate innovators accelerate to greater impact and higher valuations.

External Advisor

Emphatic Thinking

In partnership with Emphatic Thinking, we provide full-funnel solutions for sales and marketing organizations: market segmentation, positioning, demand generation, all the way through to signed contract we provide the strategic frameworks, tools, and tactical services to accelerate revenue.

Sales Engagement Consultant

Mixpo

Promoted to VP and tasked by new CEO to lead sales of newly-acquired product directly to national advertisers and agencies.  Faced with the need to deliver results quickly, I rebuilt the team and entire sales approach and discovered the transformative effect reviewing sales call recordings has on individual and team performance.

VP, Advertiser Sales

Promoted to lead the entire team empowering sellers of online media grow business with national advertisers through the use of interactive and personalized video advertisements.  Appointed to Leadership Team.

Key accomplishments:  materially changed revenue trajectory, implemented "the system" consisting of individual productivity, team cohesion, and increased customer satisfaction.

Group Director, National Resellers

Mixpo is a digital advertising technology company that enables agencies and media companies to easily create interactive video ads that run anywhere. Our video ads are multiscreen (desktop, tablet or phone), multichannel (across the web or inside news feeds of any social site) and multiformat (in-stream, in-banner or in-app). We were selected by FORBES as one of the Most Promising Companies in America in 2013 and 2014.

I lead Mixpo's Portals, Networks, & DSP Channel, bringing these publishers interactive & dynamic video ad experiences across ALL their inventory: In-stream, In-banner (including high impact ad units), tablets and smart phones.

Main accomplishments
-Grew channel from 2 to 15+ revenue-producing partners
-Increased revenue from nearly zero to hefty seven-figure annualized run rate
-Launched hundreds of new campaigns including 75 of the top 100 national advertisers
-Led Mixpo's efforts in winning 2 industry creative awards
-High client trust and satisfaction as evidenced by being "first call" when contacts moved to new companies

Senior Director, Sales and Business Development

Martini Media Network

I provided advice, guidance, and market intelligence to the CEO and advertising sales team.

Advisory Board

Optify - Marketing in Real-Time

Software and Consulting sales to Enterprise-level customers.

Director, Enterprise Solutions

Yahoo!

I led Yahoo's emerging Seattle office in achieving best-in-market sales, service, and client satisfaction until its closure in June 2010.

Designed, negotiated, implemented, and optimized advertising solutions for the largest Seattle-based national advertisers.  Expert in search, display, mobile, & ad networks.

Notable sales achievements:
-Exceeded revenue quota during entire tenure
-Increased search revenue 20+% y/y in spite of market share decline
-Largest-ever display investments by local game publisher
-First-ever Fantasy Football sponsorship by major beer advertiser
-First-ever Home Page upfront commitment from major Direct Response advertiser

Strategic Account Director

Microsoft Digital Advertising Solutions

Develop superior knowledge of client business objectives and provide best-in-industry service to consistently exceed revenue goals
• Drive revenue growth by expanding client use of brand advertising
• Prospect, develop, negotiate, and close new advertising opportunities for Microsoft
• Mentor and train new Account Executives and Account Managers
• Manage all aspects of client relationship

Account Executive

B2BWorks

Generated new business and grew relationships for business-to-business online advertising agency; supervised media planning, website development, creative, and campaign measurement teams
• Developed and implemented segmentation and sales strategy for West Coast region
• Strengthened Company’s competencies in Small Business and Technology categories resulting In major new account wins from Google, Gateway, HP, Cisco Systems and Microsoft
• Led Company sales evolution from media sales to agency service as Company changed business models
•Established name recognition within B2B advertising community: Nominated for Northern California Business Marketing Association Presidency 2004-05; regular guest speaker at Northern Nevada American Marketing Association;; guest columnist for Northern Nevada Business Weekly

Senior Director, Client Solutions

Xythos Software, Inc.

Launched, built, and grew sales team for a business-to-business startup enterprise software company
• Developed and implemented go-to-market strategy for direct and reseller channels
• Hired and managed outside telemarketing firm to generate over 15 qualified leads per week 
• Earned key account wins with Procter & Gamble and Chubb Insurance vs. Microsoft and Oracle
• Achieved profitability and revenue goals resulting in venture capital funding in tight market

National Sales Director

I put my 25 Salesforce certifications to work for <$100M companies optimizing Salesforce for long-term growth | Data Cleanup | Process Automation | Integrations | AI

Are you looking to equip your startup rocket ship with the tools and systems that successfully propelled dozens of B2B SaaS startups to over $50 million ARR?

❓ Do you trust the data in your core metrics such as ARR, NRR, CAC, LTV, and Win Rate?

❓ How much of your day is strategic vs reactive and randomized?

❓ Do you have an A system that can support an expanding sales team and weather turnover?

❓ Do you have clarity and predictability around the key drivers of pipeline growth?

As a sales leader you want to spend your time with customers, hiring & coaching reps, influencing product and growing the company.  You can't afford the time figuring out how to build a system that provides these answers.

And why should you?   B2B SaaS sales motions are remarkably similar across industries.  So why are most Salesforce implementations so expensive and time-consuming?

😡 Bloated agencies prices that have to account for under utilized consultants and exec overhead
😡 Hourly billing model removes efficiency incentive
😡 Large delivery teams to provide necessary skills and project management

After serving hundreds of B2B SaaS startups, we've found that over 60% of customer requirements are the same.  So we built a better way to deliver. 🚀🍕🌈🍕🌻🚀  

Our Rocket SaaS system encapsulates all the strategic guidance and technical implementation into a logical, step-by-step framework that turns your GTM strategy into system reality in a fraction of the time and cost of legacy providers.

So Imagine:

🚀Knowing the current and next quarters forecast accuracy with extremely high confidence
🚀Having an early warning system for deals at risk
🚀Onboarding customers faster with higher daily usage and increasing Net Revenue Retention
🚀Receiving stellar CSAT scores and easier-to-gather testimonials

We have these solutions ready-to-go for you.  We'll tailor to your specific needs, just as you can customize your car, but we're not recreating the wheel each time.

A favorite customer quote:
“As a leading Sales Technology provider, we  already knew a lot about Salesforce and Outreach. However, Acoustic has raised our game even higher.  What sets them apart is their ability to dig deeper  to get to the core business issues.  Unlike other consultants, they go just as deep into our business as much as our technology.” Matt Millen, CEO, Regie.ai.

taplio

The Battle

Neelank Tiwari, MS, PMP

Kevin Ascher

Followers

Posts

Engagements

Likes

Ready to grow your LinkedIn presence?