Aleksandar Marinkovic, Sc.D.

adspub@r.postjobfree.com 617-***-**** https://www.linkedin.com/in/marinkovicalek

Brookline, MA 02446

Engineer-scientist, research and development innovation leader with more than 15 years of experience in digital health, embedded systems, medical devices, life sciences and biotechnology. Experienced engineering manager who works to bridge the space between strategic vision and new product development. Built and led cross-functional teams in all stages of development of medical devices and diagnostic instrumentation. Led planning, development, manufacturing, and deployment of cybersecure embedded medical device software. Applied systems engineering in complex product development. Expert in design controls and medical device design verification testing. Expert in product development lifecycle management. Expert in design and prototyping of user-centered electro-mechanical devices and systems. Trained and researched in regenerative medicine and tissue engineering, physiology of lung and muscle, microfluidics, and organs-on-chip.

Expertise in:

Building Technical Organizations

Engineering Management

Hiring and Mentoring Junior and Senior Engineers

Interviewing Candidates

Medical Devices – R&D and Regulatory Compliance

Digital Health

Digital Transformation

Technology and Science Communication and Leadership

New Product Development

Product Development Lifecycle Management

Hardware Development and Manufacturing

Software Platform Development – CD/CI

Cybersecurity – Planning, Development, and Deployment

Systems Engineering

Control Systems and Algorithms

Embedded Systems

UX/UI

Data Engineering, Machine Learning

Wearable Sensors

Minimally Invasive Surgery

Tissue Engineering and Regenerative Medicine

Biomedical Engineering

Select accomplishments:

●Led Medtronic’s GYN Health R&D digital transformation, device and embedded software development.

●Built and led cross-functional teams developing medical hardware devices and embedded software.

●Created and implemented medical device hardware, software, and cybersecurity development, manufacturing, and deployment roadmaps.

●Architected hardware and embedded software for diagnostic and therapeutic medical devices.

Experience:

Medtronic, Woburn, MA (Hardware/Software/Systems Engineering Manager) 2021 – now

●Built and managed a team of software engineers, including embedded Linux and Free-RTOS developers, embedded platform engineers – Linux/Yocto, and Qt C++ GUI programmers.

●Managed a team of electrical, mechanical, systems and R&D engineers. Management duties involved hiring, annual individual goals setting, career development planning, and performance reviews.

●Demonstrated strong leadership skills, ability to motivate highly talented teams and the ability to inspire others.

●Prioritized and balanced multiple competing priorities within and across multiple projects.

●Drove cybersecurity planning, secure software development, deployment, and post-market surveillance

●Drove technical development of innovative surgical devices and provided leadership in a fast-paced environment. Took responsibility for the overall planning, execution and success of complex technical projects. Contributed technically to projects and design reviews.

●Worked closely with product management and quality engineering teams to ensure building the best GYN Health products.

●Supervised implementation of change design process for legacy minimally invasive surgical capital equipment.

Medtronic, Woburn, MA (Principal R&D Engineer) 2018 – 2021

●Led technology innovation in line with Medtronic GYN product roadmap. Designed system architecture for hysteroscopic tissue removal and fluid management systems.

●Supervised embedded software development for next generation hysteroscopic tissue removal and fluid management systems.

●Performed functional analysis, timeline analysis, detail trade studies, requirements allocation and interface definition studies to translate customer requirements into hardware and software specifications.

●Ensured the logical and systematic conversion of product requirements into total systems solutions that acknowledge technical, schedule, and cost constraints.

●Worked with internal and external resources to develop prototypes that integrate candidate technologies and demonstrate their feasibility.

●Oversaw the development of technology demonstration prototypes and addressed technical challenges as those arose.

●Conceived new approaches and developed Technology Requirements.

●Supported the creation of chartering documents to seek management approval for funding and execution of GYN projects.

●Supported the evaluation of development partners and acted as a key contact person for the duration of the project.

●Created RACIQ matrices to enable project development activities, and manage and coordinate geographically remote R&D teams; led initiation and execution of projects across interdisciplinary teams.

●Led ideation sessions; created IP and prepared invention disclosures in focus areas.

●Mentored senior and junior engineers.

●Implemented product development lifecycle management system to ensure traceability of all stages of the medical device development process.

●Led V&V activities, created test plans, designed test analogs for subsystems, and supervised writing and execution of test protocols.

●Developed and implemented digital control algorithms for BLDC motors and hysteroscopic fluid management system pumps.

●Designed RFID reader for validation of disposable tissue shavers and automatic setting of operational parameters.

Smith & Nephew, Andover, MA (Staff Systems Engineer, R&D) 2017 – 2018

●Worked and led within a cross-functional team to design, develop, test, and document innovative system solutions for arthroscopic surgery; the system utilized opto-electro-mechanical and fluidic system components.

●Led design of the BLDC motor assembly and controller for arthroscopic shaver system. Worked with OEM and accomplished the development of the next generation of BLDC motor capable of withstanding harsh operating conditions (exposure to saline and autoclave).

●Investigated and defined system features. Worked with other engineering disciplines to ensure proper implementation.

●Worked with marketing to define user requirements and performed feasibility studies.

●Developed system validation and verification protocols and performed testing.

●Developed control system algorithms and translated them into embedded software ensuring proper performance of shaver handpiece.

Morgan Scientific, Haverhill, MA (Director of Development/Engineering) 2016 – 2017

●Led the development of advanced signal processing algorithms for pulmonary function testing (PFT) instruments. Designed and wrote a signal processing module for the ComPAS PFT software suite.

●Developed a method to rapidly measure lung volumes with body plethysmography without the need for thermal equilibration of the device. The method vastly improved user experience, especially for children.

●Implemented instrument control, integrated fast gas sensors and developed calibration procedures.

Wyss Institute for Biologically Inspired Engineering, Boston, MA (Postdoctoral Fellow) 2015 – 2016

●Developed a tri-culture of primary human cells on the Organs-on-Chip microfluidic platform.

●Identified acute cytokine and lipid mediator responses in the cell culture model of lung fibrosis after ionizing radiation exposure.

Morgan Scientific, Haverhill, MA (New Product Development/Software Development/Algorithms) 2008 – 2016

●Worked as a technology development consultant; made improvements of user-centric software, processes and systems included in Pulmonary Function Testing (PFT) diagnostic instrumentation.

●Designed and implemented the single- and multi-breath nitrogen washout PFTs.

●Wrote C# code, including advanced signal processing algorithms for PFT devices.

Matrigen Life Technologies, Brea, CA (Technology Developer) 2011 – 2013

●Supervised engineering of the ‘softwell’ technology that replicated a broad range of physiological tissue softness, from fat to contracted cardiac muscle, so one can routinely venture beyond the rigidity of tissue culture plastic and study tissue fibrosis development in pathophysiologically relevant mechanical milieu.

Massachusetts General Hospital, Boston, MA (Postdoctoral Fellow) 2013 – 2014

The Laboratory for Tissue Engineering and Organ Fabrication, The Center for Regenerative Medicine

●Designed a next generation of biomimetic scaffolds for liver tissue engineering.

●Engineered skeletal muscle tissue constructs.

Harvard University, Boston, MA (Graduate Student) 2007 – 2012

Harvard School of Public Health, Molecular and Integrative Physiological Sciences

●Developed a high-throughput, traction-based functional assay for studying contractility of single cells and used this tool to identify the mechanisms involved in matrix stiffness-induced activation of lung fibroblasts; suggested novel strategies for treating idiopathic pulmonary fibrosis.

●Developed ‘TractionsForAll 2015’ (https://tractionsforall.wixsite.com/tractionsforall), freely distributed software that computes tractions exerted by the adherent cells on soft hydrogel substrates.

Massachusetts Institute of Technology, Cambridge, MA (Graduate Student) 2005 – 2007

Department of Mechanical Engineering, d'Arbeloff Lab for Information Systems and Technology

●Developed a method for calibration of wearable photoplethysmograph sensor for continuous blood pressure monitoring.

Harvard School of Public Health, Boston, MA (Graduate Research Scholar) 2003 – 2005

Department of Environmental Health, Physiology Program

●Developed a real-time virtual loading system used to discover the relaxation effect of deep breathing on airway smooth muscle undergoing spastic response as in asthmatic attack.

Water Supply Company, Kragujevac, Serbia (Staff Engineer, Control Systems) 2002 – 2003

●Supervised control and monitoring of drinking water treatment and distribution.

ECM Industrial Electronics, Kragujevac, Serbia (Intern) 2001

●Developed digital PID controller automatically tuned by using relay feedback approach.

Education:

Postdoctoral Fellow, Wyss Institute for Biologically Inspired Engineering, Harvard University 2015 – 2016

Area: Organs-on-Chip, Biomimetic Microsystems, Disease Modeling, Microfluidics

T32 Postdoctoral Fellow, Massachusetts General Hospital 2013 – 2014

Area: Tissue Engineering, Regenerative Medicine, Translational Medicine, Microfluidics

Award: Kirschstein National Research Service Award in Tissue Engineering and Regenerative Medicine

Doctor of Science, Molecular and Integrative Physiological Sciences, Harvard University 2007 – 2012

Area: Bioengineering, Physiology, Mechanisms of Disease, Biostatistics, Environmental Health

Thesis: Interactions of Matrix Stiffness and Cytoskeletal Tension in Lung Fibroblast Proliferation and Fibrogenesis

Award: Ruth L. Kirschstein NRSA, graduate student fellowship

Master of Science in Mechanical Engineering, Massachusetts Institute of Technology (MIT) 2005 – 2007

Area: Control, Instrumentation and Robotics; Bioengineering

Thesis: Reconstructing the Blood Pressure Waveforms Using a Wearable Photoplethysmograph Sensor and Hydrostatic Pressure Variations Measured by Accelerometers

Bachelor of Science, Faculty of Mechanical Engineering, University of Kragujevac, Serbia 1996 – 2002

Area: Control and Applied Mechanics, Summa Cum Laude

Certificates:

Association for the Advancement of Medical Instrumentation (AAMI), Design Control Requirements – Integrating the Quality System Regulation and ANSI/AAMI/ISO 13485

Internet of Things: Business Implications and Opportunities, MIT Sloan School of Management, ID 19644928

Principles and Models for System Architecture, Massachusetts Institute of Technology, July 2018

Technical expertise and skills:

Medical device development:

Medical devices: Product development lifecycle management, System verification and validation (V&V); Minimally invasive surgery, Pulmonary function testing, Non-invasive monitoring of physiological signals

Regulations and Quality: IEC 62304, ISO 13485, IEC 60601, FDA 510(k)

System architecture: Complex systems, Multi-domain architecture, Hardware-software integration, Electro-mechanical systems, Data analytics

Control systems: Real-time control, Feedback control, Digital control, System identification, Machine learning, BLDC Motor control (hardware and software), Fluidic control systems

Embedded systems: ARM MCUs, SoCs, Xilinx FPGA, Data acquisition and mixed signal processing, Digital filters, Algorithms

UI and UX: User-machine interfacing, Seamless patient-diagnostic device interaction, GUI design and integration

Electronics: Analog and mixed signal systems, Microcontrollers, Analog and digital circuits, Wearable sensors, Physical and chemical sensors, PCB design

Design and manufacturing: Design controls, Rapid prototyping, Managing product architecture, Failure modes and effects analysis, Engineering materials, Biocompatibility

Software development:

Programming languages: Embedded C/C++, Python, C#, Visual Basic .Net, Matlab

Operating systems: Embedded Linux, Windows, RTOS

Development environments: Visual Studio, Eclipse, Qt Creator

Continuous Integration/Continuous Delivery (CI/CD): Jenkins

Requirement lifecycle management: Helix ALM (TestTrack), Polarion ALM

Source code management/Version control: GIT, Bitbucket, Azure Repos, Helix Core

Issue tracking and testing: Helix ALM, Jira

Memberships:

MIT MechE Alliance Mentoring (I help MIT MechE students to achieve their goals and build career in product development and design of medical devices.)

International Council on Systems Engineering (INCOSE), Biomedical Engineering Society, American Thoracic Society, American Physiological Society, Biophysical Society

Peer reviewer for: Journal of Biomechanics (Acta Biomaterialia), Journal of Visualized Experiments (JoVE)

Patents:

1.Nikolai D. Begg, Aleksandar Marinkovic, John R. Gearheart, “Surgical systems and methods for protecting against unauthorized use”, Pub. No.: US20210358609A1, Appl. No.: US17/308,924, Filed: May 05, 2021

2.Damian J. Cross, Jordan A. Whisler, Aleksandar Marinkovic, Steven M. Rybicki, “Outflow collection systems for hysteroscopic surgical procedures”, Pub. No.: US20210299336A1, Appl. No.: US17/132,746, Filed: Dec 23, 2020

3.Aleksandar Marinkovic, “Surgical systems for controlling an angular position trajectory for tissue shavers and other rotating surgical instruments”, Pub. No.: US20200360041A1, Appl. No.: US16/410,025, Filed: May 13, 2019

4.Haruhiko. H. Asada, Aleksandar Marinkovic, Andrew T. Reisner, Phillip Shaltis, “Apparatus and method for blood pressure measurement by touch”, Pub. No.: WO2007064654A1, Appl. No.: PCT/US2006/045590, Filed: Nov 29, 2006

Select publications:

1.Marinković A, Liu F, and Tschumperlin DJ, “Matrices of physiologic stiffness potently inactivate IPF fibroblasts”, Am J Respir Cell Mol Biol. 2013 Apr;48(4):422-30, PMID: 23258227

2.Mih JD, Marinković A, Liu F, Sharif A, and Tschumperlin DJ, “Matrix stiffness reverses the effect of actomyosin tension on cell proliferation”, J Cell Sci. 2012 Dec 15;125(Pt 24):5974-83, PMID: 23097048

3.Marinković A, Mih JD, Park J, Liu F, and Tschumperlin DJ, “Improved throughput traction microscopy reveals dominant role for matrix stiffness in fibroblast contractility and TGF-β responsiveness”, Am J Physiol Lung Cell Mol Physiol. 2012 Aug 1;303(3):L169-80, PMID: 22659883

4.Mih JD, Marinković A, Liu F, Sharif A, and Tschumperlin DJ, “A multiwell platform for studying stiffness-dependent biology”, PLoS One. 2011;6(5):e19929, PMID: 21637769

5.Luthy SK, Marinković A, Weiner DJ, “Resonant frequency does not predict high-frequency chest compression settings that maximize airflow or volume”, Pediatr Pulmonol. 2011 Jun;46(6):604-9, PMID: 21438176

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