Hire the Best Medical Devices Specialists
in the United States

Registered Patent Agent (USPTO) | Biotech, Medical Devices & Pharma Patent Drafting | Provisional & Non-Provisional Applications | PharmD I help inventors and startups protect their technology through carefully drafted and strategically structured U.S. patent applications. I am a USPTO-registered Patent Agent (Reg. No. 82855) and Doctor of Pharmacy (PharmD) with graduate-level training in biotechnology through programs at Johns Hopkins University and Northeastern University. My work focuses primarily on biotechnology, pharmaceuticals, medical devices, and other technically detailed technologies where scientific accuracy and thoughtful claim strategy are critical. I regularly draft and prosecute U.S. utility, provisional, and design patent applications and also support law firms with overflow drafting and prosecution matters. My experience includes preparing full specifications and claims, conducting prior art and patentability searches, responding to Office Actions, and developing claim strategies that strengthen scope and enforceability. I work across drug formulations, medical devices, mechanical systems, and select software-enabled technologies. My approach is straightforward: clear writing, strong technical accuracy, and applications that are built to withstand examination while supporting real business and commercialization goals. I also volunteer as an IP mentor with Nucleate, advising early-stage biotech startups on early patent strategy and portfolio planning. If you’re looking for reliable, professional patent support from someone who understands both the science and the legal side, I’d be glad to discuss your project.

I’m a Quality Assurance and Regulatory Affairs professional with over 7 years of experience leading compliance for Class I and II medical devices marketed in 20+ countries across North America, the EU, Asia-Pacific, and Latin America. I specialize in building and maintaining globally compliant quality systems and managing regulatory submissions that open new markets while keeping products in compliance. My work spans FDA 510(k) submissions, EU MDR Technical Documentation, and Rest of World (RoW) registrations — including Canada, Australia, Japan, Taiwan, Malaysia, South Korea and others. Clients appreciate my ability to translate global regulations into clear, actionable plans that teams can execute with confidence and precision. CORE EXPERTISE Regulatory & Quality Systems: FDA cGMP, ISO 13485, MDSAP, CE Mark, 510(k), PRRC responsibilities, global regulatory strategy International Market Access: Global product registrations and RoW approvals. Regulatory Submissions: 510(k), EU MDR Technical Files, Clinical Evaluation Reports (CER/CEP), PMS/PMPF, risk management documentation Quality Management: CAPA, internal audits, supplier qualification, and process validation (21 CFR Part 11, CSV) Audits & Inspections: FDA, Notified Body, MDSAP, and global authority audits with zero major findings Leadership & Training: QMS implementation, internal auditor training, and cross-functional compliance alignment WHAT I OFFER ON UPWORK # FDA 510(k) and EU MDR Technical Documentation support # RoW submissions and international registration strategy # ISO 13485 / MDSAP / EU MDR gap analysis and audit readiness # QMS documentation development, SOP writing, and process improvement # CAPA, risk management (ISO 14971), and post-market surveillance planning # PRRC and Management Representative services GLOBAL IMPACT Throughout my career, I’ve contributed to the successful registration and market access of medical devices in over 20 countries, collaborating closely with distributors, regulatory agencies, and notified bodies. I’m passionate about enabling innovation through compliance — ensuring that high-quality, safe medical devices reach patients worldwide.

I’m a mechanical and electrical engineer with over 10 years of experience, specializing in taking ideas from concept to functional prototype. My career began in industrial design and new product development, where I focused on mechanical systems, custom fixtures, and precision components. Building on that foundation, I expanded into PCB design, embedded systems, and software/firmware design, allowing me to bridge the gap between mechanical and electrical engineering for projects that demand both. My recent work includes CoreSync, a neuroplasticity-driven motor training system; Alerta, a suite of sensors for monitoring elderly patients; the Hair Protractor, a compact ring-mounted tool with integrated PCB and OLED display; and a wireless RGB headphone system with custom electronics and housing. I’ve also designed specialized cryogenic systems, industrial hardware, and automated test devices for labs. Clients value my ability to deliver complex prototypes quickly and reliably. Clients typically see working hardware within about three weeks, depending on complexity. I’ve built lasting relationships with clients like Alerta, where I’ve supported multiple sensor-based devices, and with a wireless headphone company, where I developed a full ecosystem of sensors and user interfaces. My engineering work has been published in the ASME Journal of Medical Devices, and I’ve led designs for organizations like the National Institute of Standards and Technology (NIST), giving clients confidence that I can handle demanding technical challenges. If you need an engineer who can design, build, and validate prototypes that work the first time, I can help. Keywords: Mechanical Engineer, Electrical Engineer, Embedded Systems Engineer, PCB Design, Circuit Design, CAD Modeling, SolidWorks CAD Design, Prototyping, Prototype Design, Prototype Development, Product Development, New Product Development, Electromechanical Design, Mechatronics, R&D Engineering, Wearable Devices, IoT Devices, Medical Device Design, Firmware Development, Hardware Design, Electronics Design, PCB Layout, Electronic Prototyping, Rapid Prototyping, Sensor Design, Sensor Integration, Industrial Design, Cryogenic Systems, Research and Development Engineering, Automation, Lab Automation, Design for Manufacturing (DFM), Tolerance Analysis, Finite Element Analysis (FEA), Multibody Simulation, Material Selection, Stress Analysis, Thermal Analysis, Sheet Metal Design, Machined Parts, Mechanical System Design, Assembly Design, Precision Engineering

Electronics Engineer & CEO, StepTech LLC | Full-Stack Product Development & Manufacturing Specialist I'm an accomplished Electronics Engineer with over 7 years of experience, and as the CEO of StepTech LLC, I specialize in guiding professional commercial products from initial conception to successful production. My business is built on delivering innovative, manufacturable electronic solutions for a diverse client base across medical, pharmaceutical, and entertainment industries. My expertise covers the entire product development lifecycle, bridging the gap between hardware and software. I excel at Product Design and Development, translating client visions into tangible solutions through advanced 3D printing (including industrial-grade FDM and 12k resin capabilities) for rapid, high-fidelity prototyping and user feedback integration. I also have an in house CNC machine for metal and delrin part creation. In Hardware Engineering, I possess a strong understanding of components, proficiently manage Bills of Materials (BOMs), generate production-ready Gerber files, and employ precision SMD soldering techniques. My Software Development skills enable me to create user-friendly and intuitive applications that seamlessly integrate with custom hardware. I am dedicated to exceeding expectations by delivering projects efficiently and effectively. My commitment to clear, consistent communication ensures a collaborative and successful partnership, from concept validation through to market readiness.

Former Primary Patent Examiner at the U.S. Patent and Trademark Office (USPTO) proficient in patent and prior art searching, patent claim review, and proofing-reading using the same approach as the USPTO. Relying on 11+ years of experience examining patents, my goal is to assist in saving you money and time by: - Searching prior art (e.g. published patents, journal articles, product brochures, etc.) - Reviewing patent claim language from the perspective of the USPTO - Reviewing AI and online platform generated applications for consistency, thoroughness, and errors - Understanding "Office Action" responses sent by the USPTO Other services: - Assist you in learning how to effectively search for patents and prior art on your own - Act as a "second pair of eyes" for attorney or software/AI-generate patent documents If you are tackling applying for a patent on your own, are hesitant to hire legal representation because of the cost, or just need some extra direction, feel free to reach out. The majority of my clients whom I have assisted are independent inventors or small business owners unfamiliar with the patent landscape. Though I have worked with very large corporations (see below) I have enjoyed using my experience and expertise in successfully supporting individuals with entrepreneurial spirit, as well as those that feel intimidated by the patent system. Clients whom I have aided in attaining patent protection include: Google, Amazon, Nvidia, Meta, IBM, and many others in the tech industry, as well as independent inventors and small businesses in the area of pet supplies, boating components, medical devices, food preparation, and life-saving devices, to name a few.

• US-based medical doctor (MD), plus master's of public health (MPH) and business administration (MBA). • Expert Vetted (top 1%, pre-screened by experts in the field) medical consultant, advisor, and content strategist. Past clients include BetterHelp and Labcorp, among others. • You'll be hard pressed to find another physician on Upwork who is as credentialed: I completed my internship in general surgery at Mayo Clinic, master's degrees in public health and business at Johns Hopkins University, and a postdoctoral fellowship in peripheral nerve surgery at Johns Hopkins Hospital. • For the past seven years, I've worked as a strategy consultant for the company I founded: juniper.life. By combining my clinical, scientific, and business knowledge, I've been able to deliver competitive insights that have helped clients in healthcare and biotechnology navigate complex decisions with confidence. • During my time in academic medicine, I performed extensive biomedical research, winning awards and publishing in the top medical journals. I'm currently a peer reviewer in health economics for the British Medical Journal. • Not afraid to branch out, I also completed a fellowship in medical journalism at NBC News in 2016, making me adept at science communication for diverse audiences. • As doctor and entrepreneur, my passion is to find solutions to challenging problems in healthcare and beyond. I'm uniquely qualified to address the needs of clients in the following areas: ✅ Medical content consulting and writing with an emphasis on functional and precision medicine ✅ Business strategy for health & wellness companies. ✅ Strategy consulting for life sciences companies (visit juniper.life). ✅ Science communication, including content (written & video) for diverse audiences. ✅ All aspects of clinical research, from study design to publication. ✅ Health economics & outcomes research (HEOR). ✅ Bioethics. **SERIOUS INQUIRES ONLY, please. I only endorse products I personally vet. I will not prescribe for any online pharmacies.**