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

Shell

1. Led Front End Engineering  and techno-economic assessment as Concept Lead for multiple CCS projects in South-East Asia, delivering multi-billion dollar projects with significant CAPEX savings.

2. Achieved significant CAPEX reduction for CO₂ liquefaction and export terminal through technology maturation and process lineup optimization. 

3. Developed strategic economic modelling tool for selecting optimised CCS shipping solution for cross country cryogenic CO2 transport.

4. Supported cross-functional partnerships and stakeholder engagement for CCS project portfolio across Asia-Pacific, balancing technical requirements with commercial objectives.

Senior Concept Engineer

1. Led upstream project developments across multiple global regions managing greenfield and brownfield concept selection studies, achieving major cost reductions and GHG intensity improvements.

2. Delivered substantial cost savings and emissions intensity reduction for major deepwater project through scope simplification, electrification and new technology implementation.

3. Achieved significant CAPEX optimization for offshore development in Middle East region through strategic project framing, competitive scoping, and cross-functional engineering team coordination.

4. Realized double-digit OPEX reduction pathway for South-East Asian brownfield asset life extension through systems rationalization, optimizing offshore compression and power configuration and implementing renewable energy solutions.

5. Advanced emission reduction for an onshore asset in Central Asian region by conducting blue hydrogen and CCS screening studies.

Concept Engineer (Activity Lead)

Shell | BG Group

1. Wells and Facility Management expert involved in forecasting, planning and delivery of production enhancement activities in late-life assets, generating multi-millions in annual incremental revenue as Performance & Technology Focal for offshore hydrocarbon fields.

2. Improved compression system efficiency significantly through strategic vendor collaboration, increasing gas processing throughput without additional power requirements .

3. Led end-to-end new technology deployment from market screening through field trials for upstream assets, ensuring technical specifications aligned with operational requirements.

4. Strengthened technical leadership by publishing multiple technical papers and delivering featured presentations at major industry conferences like ADIPEC.

Senior Production Technologist | Production Technologist

BG Group

1. Established Digital Oil field setup, recognized with Chairman's Award, that enabled data-driven operational excellence, delivering multi million dollar incremental revenue.

2. Extended gas field life significantly through compressor optimization project for an offshore gas asset, involving detailed technical analysis and stepwise implementation.

3. Implemented multi-million annual revenue enhancement through condensate recovery improvement project from concept to commissioning for offshore hydrocarbon operations.

4. Worked in a frontline offshore role, managing daily production on an offshore oil and gas processing complex.

Production Engineer

1. Process engineer for LNG plant FEED & EPC, delivering cost savings and safety improvements.

2. Worked in an asset support role, supporting troubleshooting, well & facilities simulation and hydrocarbon allocation.

Graduate Engineer

Indian Institute of Technology, Roorkee

Institute Silver Medal - Ranked #1 in cohort

Student

Reliance

Summer Internship

With 15+ years at Shell and BG Group, I bridge technical excellence and commercial viability in large-scale energy project development. I integrate multidisciplinary front-end engineering for high-risk capital projects spanning conventional hydrocarbon and energy transition space. This dual expertise positions me uniquely for today's evolving energy landscape.

I lead engineering and economics assessments for major upstream and energy transition projects across multiple geographies. My responsibilities include managing cross-functional technical assessments, conducting comprehensive economic evaluations, and driving strategic concept selection for projects valued from hundreds of millions to multi-billion dollars.

𝑪𝒐𝒓𝒆 𝑬𝒙𝒑𝒆𝒓𝒕𝒊𝒔𝒆

My work spans three domains that define modern energy project development.

For conventional upstream projects, I have delivered hundreds of millions in savings through strategic concept selection and innovative engineering solutions. These achievements include extending field life for mature assets, optimizing production systems, and implementing brownfield revitalization strategies.

In energy transition space, I spearhead pre-FEED engineering and technology maturation for carbon capture developments, managing multidisciplinary teams and integrating technical solutions with investment analysis to ensure commercial viability and regulatory compliance.

My digital transformation leadership generated over multi million $ in incremental revenue by establishing Chairman's award-winning digital oil field setup. This experience earned industry recognition and demonstrated my ability to drive organizational change while delivering measurable business outcomes.

𝑺𝒕𝒓𝒂𝒕𝒆𝒈𝒊𝒄 𝑽𝒂𝒍𝒖𝒆 𝑪𝒓𝒆𝒂𝒕𝒊𝒐𝒏

My core strength lies in translating complex engineering challenges into clear commercial opportunities while navigating stakeholder ecosystems. I led development planning that enables investment decisions by making technical complexity understandable to business stakeholders.

I am passionate about advancing energy solutions that combine conventional hydrocarbon expertise with innovative low-carbon technologies to create technically robust, commercially scalable, and environmentally responsible outcomes supporting global energy demands and decarbonization objectives.

Let's connect (amitoshtiwari01@gmail.com) to exchange ideas on transforming energy challenges into successful investment opportunities.

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The Battle

Neelank Tiwari, MS, PMP

Amitosh Tiwari

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