Engineering depth. Product outcomes.

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.

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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 has helped 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

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

Mentorship

Sponsors and mentors UC Irvine Mechanical & Aerospace Engineering senior-design teams, guiding student capstone projects from concept through working hardware.

Mentored projects →

Services

Flexible support for hard engineering problems

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

ClearPath QMS page →

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 → Engineering Intelligence →

How We Work

A clear path from problem to execution

Structured enough to de-risk the engagement, flexible enough to adapt as the work evolves.

Discovery

Understand the technical challenge, business context, and constraints through structured conversations with your team.

Plan

Define a scoped roadmap — technical approach, milestones, risk areas, and what success looks like.

Execute

Hands-on technical leadership and cross-functional execution — direct involvement in solving problems, not just advisory input.

Handoff

Documentation and knowledge transfer so your team can sustain progress after the engagement ends.

Projects

Proven results & case studies

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

Medical device innovation and product engineering

Precision Laser Manufacturing for Cardiac Implants

Challenge: Cardiac implant components (Nitinol, CoCr, stainless steel) needed a precision cutting and mapping method that could scale to high-volume, FDA/EU MDR-compliant production.
Approach: Led $4M+ R&D programs building femtosecond laser processing systems, including a supersonic gas nozzle designed through Star-CCM+ CFD analysis for high-pressure micro-laser cutting.
Result: 8 patents, FDA/EU MDR compliance, and a 6% production yield increase with fleet-wide deployment.

Advanced manufacturing and process engineering workflow

Advanced Manufacturing Strategy & Process Scale-Up

Challenge: Manufacturing processes for precision hardware needed to move from prototype to reliable, high-volume production without sacrificing quality or throughput.
Approach: Directed test strategy, specialized tooling/fixture design, and statistical process validation (DOE, Gage R&R, Minitab) across multiple R&D programs.
Result: Repeatable, validated manufacturing processes supporting scale-up in regulated production environments.

Data analytics workflow for engineering decisions

Data-Driven Engineering Decision Support

Challenge: Engineering teams needed faster, evidence-based ways to synthesize requirements, risk, and test data into milestone-readiness decisions.
Approach: Built custom analysis pipelines (Python, MATLAB) and Engineering Intelligence, a deterministic decision-support platform for evidence-based readiness reviews.
Result: Faster, evidence-cited readiness assessments backed by a growing automated regression-test suite.

CAD, simulation, and data pipeline integration

Connected Digital Engineering Thread

Challenge: Multi-workstream product development programs across MedTech, aerospace, and industrial clients had disconnected CAD, simulation, and data management workflows.
Approach: Architected PLM workflows (Teamcenter, NX) for design traceability, established a Digital Twin strategy, and connected simulation data management into a single thread.
Result: ~30% reduction in design iteration time through PLM/Digital Thread implementation.

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

FAQ

Common questions

What types of engagements do you take on?

Everything from focused technical advisory and feasibility studies to hands-on, fractional CTO/R&D leadership roles embedded with your team.

Do you work on-site, remote, or hybrid?

Both — engagements are scoped around what the program actually needs, from fully remote technical strategy work to on-site leadership for complex, hands-on programs.

What industries do you work with?

Primarily medical device, aerospace, and energy/advanced technology, with deep experience in FDA- and ISO-regulated development.

How long do engagements typically run?

It varies by scope — from short, focused projects to multi-month fractional leadership roles. We define the scope and milestones together before starting.

How do we get started?

Book a free consultation call below, or reach out directly to share your project details.