Shruti Aryal
Woburn
Summary
Accomplished biomedical engineer with expertise in product innovation and development at Ionic Pharmaceuticals LLC. Spearheaded a $500M market opportunity by leading cross-functional teams and overcoming technical barriers. Proficient in gel characterization and regulatory documentation, with strong leadership and problem-solving skills driving successful commercialization strategies.
Overview
19
19
years of professional experience
1
1
Certification
Work History
LEAD BIOMEDICAL ENGINEER-TECHNICAL DIRECTOR
Ionic Pharmaceuticals LLC
Woburn
01.2023 - Current
- Led end-to-end development of a novel burn wound gel dressing funded by NIH SBIR, overcoming key technical barriers to deliver a functional prototype and strong IP, supporting a $500M market opportunity.
- Directed experimental designs for formulation development, and characterized gel biomaterial properties including gelation time, mechanical strength as well as drug release kinetics via spectrophotometry.
- Developed a novel static mixture for blending of highly viscous solutions.
- Served as primary liaison with CDMOs, CROs, and vendors for biocompatibility, antimicrobial and cytotoxicity testing, manufacturing scale-up and preclinical studies in porcine and rodent models.
- Established in-house R&D infrastructure to conduct microbial assays such as zone-of-inhibition and antimicrobial challenge testing.
- Authored technical reports and invention disclosures; supported IP strategy and regulatory documentation.
- Oversaw scale-up and pilot manufacturing processes; transferred technology to contract manufacturers.
- Supported commercialization strategy by representing innovation at wound care conferences and partnering events.
SENIOR PRODUCT DEVELOPMENT ENGINEER
RENERVA LLC
Pittsburgh
04.2022 - 12.2022
- Conducted routine decellularization of porcine nerves to convert into biocompatible graft devices and established a novel method for the process.
- Led the design and execution of an iteratively modeled rat nerve gap study, managing junior scientists in developing and manufacturing nerve grafts while coordinating with an external CRO to ensure study milestones and quality standards were met.
- Authored and maintained key design control documents-including the project plan, design input/output requirements, and risk management files-for a novel nerve conduit; facilitated cross-functional reviews to align with regulatory requirements.
- Developed and managed sub-projects aligned with a grant-funded product development roadmap, ensuring clear deliverables, timelines, and team accountability.
- Conducted in-depth research on nerve anatomy and graft technologies, producing white paper and presenting strategic insights to internal R&D leadership team.
- Designed experiments, analyzed data and authored technical reports to support concept validation for a novel PNM-CAP neuroinhibitory matrix enabling project launch.
- Collaborated with external partners to co-develop novel test methods using Micro-CT imaging for preclinical evaluation.
- Proposed and evaluated product and process improvements, including the novel integration of an electrosurgical unit to enhance device performance and differentiation.
MASTER'S STUDENT AND RESEARCH ASSISTANT
University of Rochester
Rochester
08.2020 - 12.2021
- Identified a relevant clinical need by observing laparoscopic procedures and collaborating with surgeons, nurses, and academic advisors, then translated the need into a clear problem statement and developed a feasible prototype validated by general and plastic surgeons.
- As a research assistant, I contributed to a preclinical study investigating a potential therapy to mitigate COVID-19 cytokine storms in a rat model, analyzed data using MATLAB and Prism.
- Additionally, designed a conceptual upstream and downstream bioreactor process for monoclonal antibody/vaccine production as part of a graduate-level course.
- Excelled in advanced coursework in nanotechnology for biomedical applications and human anatomy and physiology.
SENIOR SCIENTIST
KIMBERLY CLARK
Sao Paulo
02.2015 - 05.2017
- Delivered technical solutions informed by consumer insights and managed end-to-end product development.
- Oversaw intellectual property activities, including drafting invention disclosures and collaborating on patent applications with the legal team.
- Trained and supervised junior scientists and interns in prototype development for large-scale consumer validation studies.
- Led global innovation and renovation projects through stage-gate processes, establishing success criteria, and driving milestone achievement in close coordination with cross-functional teams.
- Proactively communicated with technical and non-technical stakeholders to overcome complex challenges and ensure timely commercialization of feminine care products.
- Global Innovation Centre
- Created technically feasible products aligned with marketing concepts, business objectives, and consumer needs.
- Defined success criteria for consumer validation studies such as Concept & Use (C&U) and Home Use Tests (HUT), and managed external execution partners.
- Led ideation sessions, developed prototypes, and selected top designs collaboratively with marketing and engineering.
- Researched suitable materials and adhesives for product , participated in mill trials, and finalized specifications for scalable manufacturing.
- Led cross-functional teams to deliver a tampon product launch across EMEA and Australia.
- Identified region-specific regulatory requirements, including TGA submissions, and ensured successful, timely launch execution.
- Supported the relocation of the Global Innovation Center from Colombia to Brazil.
PROJECT SCIENTIST
ACRYMED INC.
Beaverton
05.2008 - 12.2014
- Developed silver- and oxygen-based dressings, gels, and lotions with optimized safety and efficacy profiles for medical device applications.
- Conducted routine product performance and antimicrobial efficacy testing, contributing to 510(k) submissions, claims substantiation, verification/validation, and stability studies.
- Maintained detailed laboratory records, analyzed data, and authored technical reports.
- Served as the primary R&D liaison for a family of silver products, coordinating with internal and external partners.
- Led the successful technology transfer of two major product lines to new manufacturers, ensuring compliance with quality and functional requirements.
- Supported quality system remediation by updating design control documentation such as design input, design output, and design risk assessments in accordance with ISO 13485 and FDA QSR standards.
- Successfully led product non-conformance investigations and CAPA implementation through to closure.
- Subsidiary of KIMBERLY CLARK Healthcare (Halyard Health)
- Developed technically feasible proof of novel product concepts in alignment with marketing and business needs leading to IP development and patent grants.
- Validated a new gel by proactively heading the plan, execution, and coordination of human subject clinical trial in collaboration with cross-functional team including global clinical affairs, quality, regulatory, production and manufacturing.
RESEARCH ASSISTANT
OREGON HEALTH AND SCIENCE UNIVERSITY
Portland
01.2007 - 01.2008
- Performed quantitative analysis of various chemicals using MS-LS and HPLC, following extensive extraction and isolation procedures.
- Coordinated testing schedules with clients and maintained accurate records, including inclusion/exclusion criteria, while organizing and managing data efficiently and on time.
- Delivered excellent assistance to the director of clinical trials in the Vascular Surgery Division, clinical research, and managed participating subjects, and administered patient questionnaires and informed consent.
- Initiated calibration curves of standards and analyzed data in Excel, also informed the subjects regarding research procedures, assisted coordinators with patient follow-up and long-term clinical assessment.
Education
Master of Biomedical Engineering - CMTI
University of Rochester
Rochester, NY, USA12.2021
Bachelor of Science - Bioengineering
Oregon State University
Corvallis, OR, USACorvallis, OR, USA
Skills
- Project and Stakeholder Management
- Product Innovation and Development
- Design Control and Regulatory documentation
- Consumer and Clinical Need Identification
- Risk Assessment & Mitigation
- Cross-Functional Team Leadership
- Root Cause Investigations and CAPA
- Technical and Scientific writing
- Cross-functional collaboration
- Risk management
- Commercialization strategy
- Technical communication
- Problem solving
- Attention to detail
- Team leadership
- Research analysis
- Gel characterization
- Experimental design
- Product development
- Regulatory documentation
- Technology transfer
- Biocompatibility testing
- Innovation presentation
- Maintenance and repairs
- Innovation and creativity
- Cross-functional communication
- Laboratory operation
- Project management
- Design control processes
- Collaborative teamwork
- Medical device design
- Technical reporting
Websites
Certification
Agile Project Management (IC-APM)
Languages
- Nepali
- Hindi
- English
- Nepali
- Hindi
Highlighted Contributions
- Directed and executed the development of a novel, cost-effective hydrogel wound dressing through rigorous engineering design and testing, combined with innovative problem-solving approaches. The resulting formulation enabled strong intellectual property positioning and unlocked a $500 million business opportunity for the company.
- Contributed to development of a novel decolorizing feminine hygiene pad design by integrating polymer chemistries into multilayer absorbent substrates to enhance stain masking, leakage protection, and overall user comfort. Successfully led cross-functional collaboration across marketing, engineering, regulatory, quality, and legal teams-spanning the U.S., LATAM, EMEA, and APAC regions-for the commercialization of new tampon and pads in Australia and multiple European and Asian countries. Proactively facilitated team meetings across global time zones to align key tasks, deliverables, success criteria, and timelines. I identified potential roadblocks and worked with urgency and focus to engage cross-functional input, resolve complex and ambiguous issues, and drive the project forward, culminating in a successful IMF stage-gate transition and successful product launches.
- Successfully validated a pipeline wound gel product by leading planning and coordination efforts across cross-functional teams, external vendors, and contract manufacturers. Executed a wide range of critical tasks under tight timelines and resource constraints, ensuring project continuity and successful milestone completion.
Patents
- Formulation of Wound Dressings and the uses thereof, US provisional patent 63/716,605, 11/05/24
- Oxygen generating bottle, US Patent 9,371,166, 12/28/12, 06/21/16
- Lotion tablet that provides oxygen, US Patent 9,205,034, 12/03/12, 12/08/15
- Layered Structure Having Sequestered Oxygen Catalyst, Australian patent 2015210906, US application number 15113877, 01/30/15, Patent pending in the US and other countries
- Absorbent articles with improved stain decolorization, US Patent 9,220,646, 03/27/13, 12/29/15
- Absorbent articles with decolorizing agents, US Patent 9,161,869, 03/27/13, 10/20/15
- Absorbent article with channel, Worldwide patent application Number PCT16/078,142, 02/29/16, 03/28/19, Patent pending
Timeline
LEAD BIOMEDICAL ENGINEER-TECHNICAL DIRECTOR
Ionic Pharmaceuticals LLC
01.2023 - Current
SENIOR PRODUCT DEVELOPMENT ENGINEER
RENERVA LLC
04.2022 - 12.2022
MASTER'S STUDENT AND RESEARCH ASSISTANT
University of Rochester
08.2020 - 12.2021
SENIOR SCIENTIST
KIMBERLY CLARK
02.2015 - 05.2017
PROJECT SCIENTIST
ACRYMED INC.
05.2008 - 12.2014
RESEARCH ASSISTANT
OREGON HEALTH AND SCIENCE UNIVERSITY
01.2007 - 01.2008
Master of Biomedical Engineering - CMTI
University of Rochester
Bachelor of Science - Bioengineering
Oregon State University