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Specialist - Medical Electronics

Min Experience

0 years

Location

remote

JobType

full-time

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About the role

Healthcare Domain Expert: Healthcare IT integration, device interoperability, EHR, AI/ML/IoT/cloud consultative design, UI/UX/competitive/strategic planning, regulatory compliance (HIPAA, FDA). Regulatory Medical Writer: Systematic literature reviews, SOTA/SD, CEP/CER, adverse event & clinical trial searches, compliance documentation for MDR/CE/FDA/international, publication screening and evidence synthesis.

About the company

Dr. Ashish Jha (Ph.D.) Date of Birth: 19.02.1988 Sex: Male Nationality: Indian Marital Status: Married Mobile: +91-9987725963 +91-8619267039 E-mail: mail@doctorashishjha.com doctorashishjha@gmail.com Website: doctorashishjha.com LinkedIn: linkedin.com/in/dr-ashish-jha Academic Qualifications M.Sc.-Ph.D. Awarded (2021): Bioscience and Bioengineering, IIT-Bombay, Maharashtra, India. Ph.D. Thesis (2019): "PPC NanoTorrid® Structure for Photothermal Therapy in Breast Cancer" under Prof. Rohit Srivastava. M.Sc. Thesis (2013): "Isophthalate Degradation by Acinetobacter lwoffii strain ISP4" under Prof. Prashant S. Phale. B.Sc. (2009-2011): Biotechnology, St. Wilfred's P.G. College, Rajasthan University, India. Skills Research Software COMSOL Multiphysics (complex modeling and simulation) SigmaPlot (enzyme kinetics, data viz.) ChemDraw (chemical design) Origin (thermal, 3D data analysis) ImageJ (cell & nanoparticle analysis) GraphPad Prism (statistics, IC50 curves) Technical Skills Nanomaterial synthesis (NanoTorrid, Nanocubons) Instrument operation: TEM, SEM, Cryo-SEM, DLS, FTIR, Raman, ICP-AES, ICP-MS, FACS, TG-DTA, XRD, XPS, MALDI, HPLC, SDS-PAGE Regulatory/Domain Software MS Office, EndNote, PubMed, Google Scholar, Embase, Cochrane, Medscape, BfArM, MedWatch, EUDAMED, Health Canada, MHRA, TGA, MAUDE, SharePoint, Teams Professional Experience Specialist – Medical Electronics at Tata Elxsi (Mar 2022 - Present) Healthcare Domain Expert: Healthcare IT integration, device interoperability, EHR, AI/ML/IoT/cloud consultative design, UI/UX/competitive/strategic planning, regulatory compliance (HIPAA, FDA). Regulatory Medical Writer: Systematic literature reviews, SOTA/SD, CEP/CER, adverse event & clinical trial searches, compliance documentation for MDR/CE/FDA/international, publication screening and evidence synthesis. Technical Business Analyst at LABINDIA Instruments (Sep 2021-Feb 2022) Pharma & biopharma customer solution design, workshops, competitive pricing/market intelligence, scientific sales enablement, product/marketing strategy. Research Associate at IIT-Bombay (Oct 2019-2021) Advanced cancer research (NanoBios Lab), extended PhD research, pre-clinical evaluation. Newton-Bhabha Fellow at Loughborough University, UK (Sep 2017-Jan 2018) Visiting PhD student; COMSOL simulation of peristaltic pump for microneedle delivery research. Research & Technical Highlights Gold Polypropylene Nanocomposite (NanoTorrid): synthesis and heat dissipation PPC Cube-Shaped Nanoparticles (Nanocubons): advanced drug delivery systems Comprehensive characterization: TEM, FTIR, Raman, ICP-MS, FACS, TG-DTA, XRD, MALDI, HPLC, XPS, Cryo-SEM, SEM Preclinical and in vivo: biocompatibility, efficacy, pharmacokinetics, distribution, renal clearance, toxicity, photothermal ablation studies Enzyme kinetics, protein/DNA purification, and metagenomics Projects Newton-Bhabha: Fabrication/modeling of pumping system in transdermal theophylline delivery (Loughborough Univ, 2017) Cancer Sensing Device (IITB, 2016) – impedance measurement Growth Cone Motility & Axon Guidance (IITB, 2013) Bioinformatics: Enzyme Degrading Carbon Compounds (IITB, 2012) Drugs targeting to the Brain (Elcon Pharma, 2010) Drug Formulation/Development (Elcon Pharma, 2009) Fellowships, Awards, and Certifications Newton-Bhabha Fellow Award (2017-18, UK) Senior Research Fellowship (IIT-Bombay 2015-19) Junior Research Fellowship (IIT-Bombay 2013-15) Master Fellowship (IIT-Bombay 2011-13) Certified Peer Reviewer (Elsevier) Six Sigma, Project Management, Agile, Product Management, Manager & Leadership, AI/ML & LLM, Generative AI Workshops & Conferences Patent Searching & Drafting (IIT-Bombay, 2016) IPR Fundamentals (IIT-Bombay, 2016) ISO 10993 Biocompatibility Training (GLR Labs, 2015) MALDI Workshop (IIT-Bombay, 2013) Advanced TEM Techniques Seminar (IIT-Bombay, 2015) Medical Device and Diagnostics Conf (Ahmedabad, 2015) Patents, Trademarks & Key Publications Jha, A., Ravichandran, G., De, A. et al. NANOTORRID®: Graphene-like properties of a gold/polypropylene nanocomposite and its photothermal application. Journal of Materials Research, Springer Nature (2022). doi Srivastava Rohit, Jha Ashish. "PPC NanoTorrid® for Photothermal therapy in Cancer," India Patent 484272 (2021). Srivastava Rohit, Jha Ashish. "Polymeric NanoCubons® nanofillers," India Patent 434460 (2021). NANOTORRID®. India Trade Mark No. 4299118. (2021). IIT Bombay. NANOCUBONS®. India Trade Mark No. 4296859. (2021). IIT Bombay.

Skills

healthcare it
device interoperability
ehr
ai
ml
iot
cloud
ui
ux
regulatory compliance
literature reviews
sota
sd
cep
cer
adverse event
clinical trial
compliance documentation
publication screening
evidence synthesis