Utmost Connect - Technical Product and R&D Leadership

Utmost Connect supports organizations in advancing complex medical device and engineering programs from concept through validation and scale, with leadership experience spanning medical devices, healthcare innovation, and advanced engineering environments.

We align engineering, clinical, and product functions to improve execution in high-uncertainty programs, with a track record that includes multi-million-dollar R&D initiatives, first-in-human clinical studies, and advanced manufacturing systems.

Advanced engineering and product development background

About

Engineering depth with product perspective

Amir Sajjadi, Ph.D., PMP · Founder and Lead Consultant · Product Development, Advanced Manufacturing, and Commercialization

Amir helps organizations turn complex technical challenges into clear, executable product and engineering outcomes.

Product Development and Commercialization
Fractional CTO / R&D Leadership
Advanced Manufacturing, Digital Engineering, and Simulation
AI-Assisted Engineering Consulting
Resume and Interview Coaching for Engineers

With 15+ years across medical devices, aerospace, energy, and high-technology sectors, he has led multidisciplinary teams from concept through scale-up and commercialization.

His background includes leadership roles with Harvard Medical School and Massachusetts General Hospital, Edwards Lifesciences, and other innovation-driven organizations.

Amir has led multi-million-dollar R&D programs, contributed to patented technologies, supported first-in-human clinical initiatives, and delivered measurable workflow improvements, including 20-40% gains in efficiency and product development performance.

Technical focus areas include advanced manufacturing, laser and micro-manufacturing, PLM and Digital Thread implementation, systems engineering, simulation-driven design, and technology strategy.

Education

Postdoctoral Fellowship, Biomedical Imaging and Translational Medicine — Harvard University

Ph.D., Mechanical Engineering — Florida Institute of Technology

M.Sc., Aerospace Engineering

B.Sc., Mechanical Engineering

Services

How can we help!

Flexible support for startups, growth-stage companies, and established teams tackling challenging product and engineering work.

R&D Strategy & Technical Leadership

Define product strategy, development roadmaps, and execution plans for complex systems.

Align engineering, clinical, and business objectives
Lead cross-functional teams and programs
Drive structured decision-making under uncertainty

Medical Device & Regulated Development

Support end-to-end development in FDA and ISO-regulated environments.

Design controls, risk management, and validation strategy
Clinical readiness and early-stage development
Design transfer and manufacturing scale-up

Laser Processing & Micro-Manufacturing

Development and optimization of precision laser processes, micro-fabrication technologies, automation, and production implementation.

Optical system design and integration
Laser-based processing and instrumentation
Precision system development and validation

Data-Driven Engineering & Analytics

Turn complex data into actionable insight.

AI-Assisted Engineering Consulting
Custom analysis pipelines (Python, MATLAB)
Statistical modeling and performance optimization
Data-driven decision support

More info and Project Examples ›

Projects

Proven Results & Case Studies

Demonstrating how complex technical challenges are translated into clear outcomes and performance improvements.

Clinical research and translational engineering collaboration

Clinical and translational program support spanning research, engineering, and execution.

Structured product development: from concept through design transfer.

Data analytics workflow for engineering decisions

Data analytics and decision-support workflows for engineering and product performance.

Advanced manufacturing and process engineering workflow

Advanced manufacturing strategy and process optimization for scalable product execution.

Medical device innovation and product engineering

Medical device innovation programs focused on design, validation, and clinical impact.

Optomechanical system design and development

Optomechanical system development combining precision design, testing, and optimization.

Laser process engineering and system development

Laser process development and system-level engineering for high-performance applications.

Supersonic nozzle simulation and engineering

Optomechanical and fluid systems: advanced engineering problem solving.

Cross-functional engineering leadership and execution

Cross-functional engineering execution and technical leadership in action.

PLM-based product lifecycle and engineering workflow

PLM-integrated engineering workflow: design, simulation, and lifecycle management.

CAD, simulation, and data pipeline integration

Connected digital engineering thread: CAD + simulation + data pipeline powered by PLM.

Medical device development and innovation

Medical device platform development in regulated environments.

Why us

What Makes Us Different

Utmost Connect is built for organizations that need more than generic consulting — they need someone who understands the technical details, bridges functions, and drives execution.

Engineering + Clinical Hybrid

Rare combination of deep technical expertise and real-world clinical experience

Hands-On Leadership

Not just strategy — direct involvement in solving problems and executing

Proven in Regulated Environments

FDA, ISO, GCP experience across the full development lifecycle

Built for Complex Problems

Comfortable operating in ambiguity, high-risk, and early-stage innovation

Contact

Let's talk about your next project

Whether you need technical leadership, product development support, or engineering analysis, Utmost Connect can help you move faster with greater clarity.

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