EDUCATION

CSI Wakeman School, Palani, India

Primary education

I understand primary education as my schooling that laid the foundations for developing my attitude to organised, collaborative work, I have come to understand, as the backbone of my accomplishments throughout my career balancing personal and social interests.

Government Girls High School, Palani, India

Secondary and higher secondary education

I understand secondary and higher secondary education as my schooling that laid the foundations for developing my values, I have come to understand, as the life blood sustaining the development of my attitude to organised, collaborative work in personal, professional and social engagements.

PSG College of Technology, Coimbatore, India

Master’s Degree, Applied Sciences

I understand tertiary education as my schooling that laid the foundations for developing adequate domain knowledge to commence a career, in this case, in Applied Sciences.

The master's degree constituted three years of study in Applied Mathematics, Applied Physics and Applied Chemistry as equal majors, followed by two years of in depth study on Material Science, as a derivative of Applied Physics. The degree included two course unit equivalent of research, my own topic of research being phase transitions in cholesteric liquid crystals

Raman Research Institute, Bangalore, India

Research Fellow, Liquid Crystals

I understand scientific research as the pursuit of inquiry into one or more specific unknown aspects of one or more inanimate matter, living species(including humans) or one more aspects of their interaction with one or more other inanimate matter or living species(including humans).

The core intent of my research was to develop liquid crystal mixtures with adequate response/performance characteristics to enable the development of 64 x 64 matrix multiplexed displays. The research included effect of surface preparation on enhancing the response characteristics and original (published)observations of spontaneous breaking of symmetry in to patterns of defects at the liquid-crystal- liquid phase transition.

Its my unstated field of study, viz., cosmology and integration of conscience within the realm of physics that found fruition in through my booklet, Omniverse[ISBN 978-06451052-5-4], self-published in 2021, after several failed attempts to find engagement/collaboration opportunities since 2020.

Macquarie University, North Ryde, Sydney

Master’s Degree, Computer Science

I understand tertiary education as my schooling that laid the foundations for developing adequate domain knowledge to commence a career, in this case, in Computer Sciences.

The four year part time program included a year of prerequisite and one year of research. My thesis on a browser for selecting ADA design packages(patterns) was preceded by a comprehensive literature research on Designing the Human-Computer Interface.

Continuing professional education

numerous workshops and courses

I understand continuing professional  education as my professional off-the-job education/training to develop/enhance/maintain currency of  understanding of one or more aspects of domain knowledge associated with the requirements of the role held or general career progression.

I have completed the requirements of numerous workshops and courses during my career; below are examples of topics of discussion|provider|sponsor:

• Seminar on Software testing imparting insights from Lockheed-Martin practices (at Essams)

• Defence grade project configuration management systems (at Essams)

• Capability Maturity Model and assessment of capability to CMM (at Essams)

• Review/Inspection techniques by Michael Fagan Associates (at GEC Marconi)

• Object oriented design and programming (at GEC Marconi)

• Comprehensive suite of workshops on Medical device product development/verification/validation to ISO 13485 by Noblitt & Rueland (at ResMed)

• Personal Software Process - self study (at ResMed)

• Software Validation with regulatory perspective by Noblitt & Rueland (at ResMed)

• Business writing by ResMed's learning centre (at ResMed)

• PRINCE 2 Into and Professional (post Westpac)

• ISO 13485 internal auditor (at Covidien)

• Train the trainer (at Covidien)

I also participated in NSW Enterprise Workshop, UTS, Sydney as a ResMed affiliate, developing a business plan for "sleepwell", franchises to distribute sleep solutions.

The six month work-shop included lectures, preparation and defence of a business plan to a panel of industry experts. Our team of three developed and defended a business plan for franchises of "Sleepwell" clinics for socialising and selling ResMed sleep solutions.

EXPERINCE

My 24 year career spans large multinationals serving the defence and medtech industries working for GEC Marconi/British Aerospace(BAE Systems), ResMed, Medtronic Australasia and worked to deliver solutions fit for large multinationals to Atcor Pty Ltd, to ARCS delivering advanced professional education in regulatory affairs and to Navbit Pty Ltd implementing IEC 62304 requirements with in existing ISO13485 QMS in a short term role. I have always aligned my priorities with business intent; once prioratised, I have given my all to the task on hand, striving for opportunities for structural correction annulling cavitations potentially leading to human harm, with limited chance of natural recovery. As with good preventions, I would count the success of my contribution by the organisation never having to remember it ever again.

Significant professional accomplishments include:

• sarigaed (seamlessly stepped-up) to mitigate key resource unavailability and developed the software requirements for a business critical defence project (GEC Marconi, 1999)

• established software design control rigour for health informatics (known as data management at that time) without compromising time line commitments (ResMed, 2000-2002)

• enforcing requirement traceability matrix for health informatics (known as data management at that time), including designing and implementing a requirements management tool in Microsoft Access raising up to the quality needs under budgetary constrains (ResMed, 2002)

• pioneering initiatives to establish homogenized system engineering processes through an overarching system specification and data dictionary to channel clinical and regulatory requirements such that they are applied and validated consistently to all subsystems (ResMed, 2002-5)

• designing regulatory compliance strategy based on interfaces rather than specific products and designing a gateway for revisiting hazard analysis post- subsystem-design (ResMed, 2002-2005)

• identifying and executing the strategy to drive efficiencies in software development and testing by adopting the risk based approach prescribed in IEC 62304, enabling the submission of the first device for FDA approval compliant with IEC 62304 (ResMed, 2005)

• understanding and simplifying the processes required to successfully bring products to market in Latin America, with significant direct benefits on the amount and type of documentation supplied, together with benefits to approval times in these otherwise sometimes difficult, developing markets (ResMed, 2006)

• developing/enabling the processes for assessing off-shore software vendors for servicing the medical device industry on behalf of ResMed and led the first off-shore software development effort within ResMed Product Development (ResMed, 2007)

• leading the delivery of the first FDA approved end-to-end wireless Health Informatics system for changing the therapy parameters of another medical device using GSM technology (ResMed, 2009)

• leading/enabling the resolution of an eluding software correction of Class IIb product liaising with the overseas manufacturer and the Australian regulator (Covidien, 2013)

• influencing the manufacturer of health informatics product to raise the bar on regulatory oversight by seeking full conformity assessment (Covidien, 2014)

• transfer the ARTG inclusions of over 20,000 products upon acquisition while continuing to render support to Market access/post market support (Medtronic, 2016-2017)

• enabling/supporting resolution of significant field issue on a class IIb device, arising potentially from misalignment of risk/perception of risk liaising with senior management and the Australian regulator (Medtronic, 2015- 2017)

• delivered regulatory conference streams, developed and delivered medtech workshops, and a virtual summit on MDR (ARCS, 2018- 2020)

• Contributed via public consultations to the project on the human rights implications of new technology.(Australian HumanRights commission, 2018-2021)

• founded lzerobzero; developed original content, brand trinkets, built and released its website; developed several columns; piloted an original dance production; patented ground breaking ideas (lzerobzero, 2018-2023); visit lzerobzero.com or its offshoot thaureyam.com for details.

CULTURAL PURSUITS

I also write and self-publish non-fiction and poetry as adaptations of various classical works, under the auspices of lzerobzero. Note lzerobzero is a sole-trader entity I founded in 2018, with the intent to grow it as a social enterprise, imparting my insights; visit lzerobzero.com or its offshoot thaureyam.com for details.

Sincerely,

Sumathy

17 JAN 2024