Product Development R D

Amir Sajjadi, Ph.D., PMP (US Citizen)

Irvine, CA 92656, USA Contact: 321-***-****, ****.******.*******@*****.*** 1

SUMMARY OF QUALIFICATIONS

With over 12 years of experience in R&D and product development across the medical devices, energy, and aerospace industries, I bring strong technical and leadership skills within highly regulated environments. My expertise includes innovative design, prototyping, manufacturing and process development, testing, and risk analysis, with a deep background in femtosecond lasers, optomechanics, photonics, FEA, and CFD. I have led initiatives involving Lean Six Sigma methodologies, process validation (IQ/OQ/PQ), and small tooling and fixture design. Skilled in Design of Experiments (DOE), statistical analysis using Minitab, and technical documentation, I have also supported CAPA, and audit readiness processes. Additionally, I hold several patents and have contributed to the development of platform technologies and IP strategy.

EMPLOYMENT HISTORY

Sr. Principal Engineer, Inbrace

Product Development & Data Engineer, Irvine, CA, USA, Jan 2025 – Present

● Conducted advanced data analysis and designed data pipelines using Python to optimize product performance.

● Applied Lean Six Sigma tools to drive continuous improvement and reduce variability. Technical Product Development Manager, Saratech

Product Development, Mission Viejo, CA, USA, Aug 2023 – Dec 2024

● Led cross-functional teams to deliver new product designs and digital twin models using NX/Teamcenter.

● Implemented DOE methods and Lean Six Sigma strategies to improve system reliability and design efficiency.

● Developed and maintained project charters, schedules, budgets, and technical documentation.

● Designed and validated small tooling, jigs, and fixtures to support testing workflows.

● Authored and revised technical procedures and supported internal quality audits. Senior Principal Engineer, Edwards Lifesciences

Advanced Technology, Metal Center of Excellence, Irvine, CA, USA, Feb 2019 – Jun 2023

● Oversaw R&D programs exceeding $2M in scope with contributions to IP strategy and patent submissions.

● Led R&D projects focusing on dual femtosecond laser processing and characterization and imaging devices

● Led IQ/OQ/PQ validations, authored protocols, and supported GMP-compliant documentation.

● Conducted DOE and statistical analysis using Minitab for process optimization and reliability studies.

● Designed and validated specialized tooling and test fixtures for laser-based device development.

● Managed CAPA workflows, coordinated cross-department audits, and led root cause investigations.

● Created statements of work, capital forecasts, and collaborated with vendors on quoting and project delivery. Senior R&D Engineer, Massachusetts General Hospital, Instructor in Radiology, Harvard Medical School, Department of Dermatology Cutaneous Biology Research Center, Boston MA, USA, May 2014 – Jan 2019

● Led the development and integration cutting-edge medical devices, cancer diagnostics devices.

● Successfully managed complex projects from concept to commercialization, ensuring technical excellence, cost- effectiveness, and regulatory compliance with ISO 13485, EU MDR and UKCA.

● Conducted feasibility studies, prototyping, and modification of laser medical devices, resulting in improved performance, and expanded product offerings.

● Collaborated with cross-functional teams, including physicians, physicists, technicians, and engineers, to drive innovation and achieve project objectives.

● Directed and executed phase-I human clinical trial of a novel breast optical imaging system.

● Conducted comprehensive data analysis and statistical assessment across multiple datasets using MATLAB. Senior R&D Intern, Lighting Science Inc.

Lighting Science Group Corporation, Melbourne, FL, USA, June 2012 – Oct 2012

● Developed laser material deposition techniques for semiconductor/LED industries.

● Led the establishment of a Laser Lab and trained engineers in laser experiment design and characterization. Research Assistant, Laser Optics, and Instrumentation Lab (LOIB) Amir Sajjadi, Ph.D., PMP (US Citizen)

Irvine, CA 92656, USA Contact: 321-***-****, ****.******.*******@*****.*** 2

Florida Institute of Technology, Melbourne, FL, Aug 2007 – May 2012

● Engineered a groundbreaking system employing Ultra-Short Pulse Laser for tumor ablation and imaging.

● Proficient in histology and immunohistochemistry to study the laser ablation effects and wound healing.

● Developed numerical models to simulate invasive interaction of short-pulse laser with biological tissue.

● Provided direct supervision to 4 master’s students and lectured the course “Intro to ME” across 4 semesters. Research and Development Engineer, Mechanical Design Department Energy Research Institute, Tehran, Iran, Mar 2006 – Jul 2007

● Performed CFD and FEA modeling to streamline the cost by optimizing the design and production process of gas turbine and centrifugal pumps

● Enhanced the design and prototyping of blades and scroll assembly using ANSYS, Fluent and SolidWorks. Design Engineer, Mechanical Design Department

Maher Consulting Company, Tehran, Iran, Dec 2003 – Feb 2006

● Designed and executed industrial HVAC and piping systems for prominent hospitals and sports complexes.

● Supervised a team of 4 field engineers in implementation of HVAC design; aided a team of 12 engineers in generating as-built drawings; reviewed and analyzed the project costs and approved financial analysis reports. EDUCATION

Postdoctoral Research Fellow, Harvard/MIT/MGH Martinos Center for Biomedical Imaging, Nov 2012 – May 2014 Conceptualized and engineered the pioneering multimodal MRI-Optical-Elastography device tailored for breast cancer imaging, culminating in the acquisition of preliminary data pivotal for securing a $500K NIH grant. PhD, Mechanical Engineering, Biomedical Optics, Florida Institute of Technology, USA, May 2012 Secured $225K in funding through fellowships & scholarships, 4 travel awards, 1 industrial grant. MSc, Aerospace Engineering, CFD, Iran University of Science and Technology Iran, May 2005 Full tuition-fee scholarship, Distinguished Graduate Student Award. BSc, Mechanical Engineering, Thermal Sciences, University of Science and Technology, Iran, May 2002 SELECTED PATENT (out of 8)

Amir Y Sajjadi, Stefan A Carp, and Dieter Manstein. “System and methods for monitoring phase kinetics in biological tissue using near infrared spectroscopy.” PCT Patent Application No. 62/393,743, September 2016. SELECTED REPORT

Amir Sajjadi, et al. “Lumenis-MGH Dual-Wavelength Laser Tissue-Tightening Study.” Phase-2b Animal Study Report, Massachusetts General Hospital, April 2015.

PUBLICATIONS: Full list can be found here: LinkedIn SKILLS

Technical skills: product development, project management, quality assurance, regulatory compliance, Six Sigma Green Belt certified, ISO standards, statistical analysis, DOE, ANOVA, GMPs, Optical Imaging Business skills: PMP certification, strategic planning, budget management, team leadership, stakeholder management, market analysis, Tech transfer & commercialization, Intellectual Property development, Patent writing Personal skills: strong communication, problem-solving, decision-making, and ability to drive results, great work ethics and initiative, critical thinking.

SELECTED ACADEMIC AWARDS, HONORS AND RECOGNITION

● Editorial Board Member of 8 International Journals: Contributed as reviewer and guest editor.

● Scientific Committee Member: 2nd IC: SCCE, Athens, Greece, July 2006

● Outstanding Graduate Student Award (2011) in Mechanical & Aerospace Engineering (top 3% of grad students), 4 years (2007 to 2011) of Graduate Research Fellowship, Research Grant Funded by Edmund Optics ®(2011), 4 Travel Grants: American Society of Laser in Medicine (2009, 2010 and 2011) and 2011 ASME Summer Bioengineering conference, Florida Tech President Fellowship (Spring 2008),

● Session Co-Chair: 14th Annual Conference of Iranian Mechanical Engineering Society, May 2006

● Member: Pi Tau Sigma, International Mechanical Engineering Honor Society, ASME, OSA, BMES

● Vice President: Florida Tech Persian Association (2009-2012), Chair: MGPA social committee (2015-present)

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