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Project Title: Medical Device V&V Testing — Contract Biomedical Engineer (Bay Area, 4-6 weeks) Description: We're an early-stage medical device startup preparing an IRB submission for an early feasibility clinical study of an Intermittent Hypoxic-Hyperoxic Therapy (IHHT) device. We need an experienced contract biomedical engineer to execute verification and validation testing on 3 prototype units in the San Francisco Bay Area, starting mid-April 2026. Scope of work: FiO2 & gas delivery characterization — measure oxygen concentration accuracy across the operating range (8-35% FiO2) using calibrated external oxygen analyzer and flow meter. Continuous logging over extended test sessions to characterize PSA cycling dynamics, transient behavior, and stability. System safety & fail-safe verification — verify SpO2 safety thresholds, BLE disconnect failsafe behavior, communication timeout response, power loss recovery, FiO2 boundary enforcement, and hypoxia time cap. BLE protocol conformance — develop a BLE test harness to systematically test all 13 device commands per the manufacturer's protocol spec. Verify CRC validation, watchdog timeout, command rejection, and data accuracy. Alarm verification — verify temperature, voltage, and sensor failure alarms against manufacturer specifications. Confirm audibility and priority levels. Test report documentation — formal V&V test reports suitable for inclusion in an IRB submission package and eventual FDA pre-submission. What we're looking for: - Medical device V&V experience (IEC 60601 family familiarity strongly preferred) - BLE / embedded systems testing capability (must be able to develop or commission a custom BLE test harness) - Access to or willingness to rent: calibrated medical-grade oxygen analyzer, flow meter, BLE development kit - Bay Area based or willing to work on-site for 4-6 weeks - Familiarity with FDA regulatory submissions (510(k), IDE, or IRB packages) a plus Timeline: Mid-April through end of May 2026 Location: San Francisco Bay Area (on-site work required — testing physical hardware) Budget: $15,000-$25,000 depending on experience and equipment Test protocols and acceptance criteria are already defined in our V&V plan. We provide the prototype units, manufacturer documentation (schematics, BOM, software architecture, BLE protocol spec), and regulatory context. You execute the testing and deliver formal reports.
Projekt-ID: 40274109
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12 Freelancer bieten im Durchschnitt $17.417 USD für diesen Auftrag

Hello, As an experienced contract biomedical engineer, I specialize in conducting the precise type of verification and validation testing your medical device project requires. I have significant expertise in executing V&V protocols conforming to IEC 60601 standards, and my extensive background in embedded systems testing and BLE protocol conformance gives me the unique advantage of being able to develop or commission a custom BLE test harness to systematically test all 13 device commands as per your specific manufacturer's protocol spec. Additionally, my profound knowledge encompasses other essential aspects of your project such as oxygen concentration accuracy measurement, safety/failsafe verification, alarm testing, and formal report documentation. My familiarity with FDA regulatory submissions will also be instrumental in ensuring that your IRB submission is fully prepared and comprehensive. I also bring a suite of high-quality tools and equipment to the table to ensure accurate testing and validation. Being based in the San Francisco Bay Area gives me easy access to quality rented medical-grade oxygen analyzers, flow meters, and BLE development kit, a practical aspect important for your project. Having managed diverse projects before, I understand the precise needs of early-stage startups like yours from initial feasibility to eventual FDA pre-submission stages. Let's transform your ideas into reality while exceeding your expectations! Thanks!
$20.000 USD in 3 Tagen
7,5
7,5

Hello Sir , as I am computer and testing engineer with master degree in engineering besides i am certified software architect from NI Emerson which is expert in test and measurement so may i can help you please , thanks
$22.000 USD in 7 Tagen
5,3
5,3

Hello, I am an experienced biomedical engineer with extensive medical device V&V expertise, including IEC 60601 compliance, BLE/embedded systems testing, and regulatory submission support. I can execute FiO2 gas delivery characterization, system safety and fail-safe verification, BLE protocol conformance testing, and alarm verification on your IHHT prototype units. I will develop or commission a BLE test harness, utilize calibrated oxygen analyzers and flow meters, and provide continuous logging to characterize device performance. All work will be documented in formal V&V reports suitable for IRB submission and eventual FDA pre-submission. I am available to work on-site in the San Francisco Bay Area for 4–6 weeks starting mid-April 2026. Questions: Are the prototype units already instrumented for data logging, or should I integrate external measurement tools? Is there a preferred format/template for the IRB-ready V&V reports? Thanks, Asif
$20.000 USD in 15 Tagen
5,1
5,1

As a seasoned engineer with a diverse range of experiences, I possess the versatile skill set to tackle your medical device V&V testing project head-on. In particular, my expertise in industrial automation parallelly aligns with your expressed needs for precise system characterizations not unlike those you require for the FiO2 gas delivery aspect. Further to this, I have the ability to work with BLE and embedded systems, making me a perfect fit for executing the BLE protocol conformance and developing custom test harnesses you mentioned. Moreover, while my previous work largely focused on industrial plants and applications, it is widely accepted that mechanical and electrical engineering demands overlap significantly. This means that my dexterity in understanding complex schematics and working under documented procedures - a requirement for your project - is second nature to me. My familiarity with Honeywell DCS C200 can also lend itself well to gathering important data for testing & monitoring purposes.
$20.000 USD in 30 Tagen
5,0
5,0

I am an experienced biomedical engineer with a strong background in medical device verification and validation, particularly with IEC 60601 standards. My extensive experience in BLE protocol testing and safety verification equips me to effectively handle your requirements for FiO2 gas delivery characterization and more. With access to necessary testing equipment and a commitment to thorough documentation, I am well-prepared to contribute to your IRB submission and ensure compliance with FDA expectations. Choosing me guarantees a reliable partner dedicated to maintaining the highest quality standards in your project.
$15.000 USD in 7 Tagen
2,8
2,8

With over 10 years of experience in web and mobile development, including expertise in blockchain and AI/ML, I understand the importance of precision and thoroughness in medical device verification and validation testing. Your project for Medical Device V&V Testing in the SF Bay Area starting mid-April poses unique challenges such as FiO2 gas delivery characterization, BLE protocol testing, and safety verification, all of which require meticulous attention to detail and expertise in IEC 60601 standards. My past experience in HealthTech and regulatory compliance aligns closely with your project requirements. I have successfully delivered projects in the healthcare domain, ensuring thorough testing and compliance with stringent guidelines. My proficiency in handling BLE protocol conformance and embedded systems testing will prove invaluable in executing the required verification and validation testing for your IHHT device. I am eager to bring my expertise to your project and help you achieve successful outcomes within the specified timeline and budget. Please feel free to reach out to discuss further details and take the next steps towards a successful collaboration on your Medical Device V&V Testing project.
$16.000 USD in 75 Tagen
0,0
0,0

Hi there,Good morning I am Talha. I have read you project details i saw you need help with Testing / QA, Biomedical Engineering, Engineering, Electrical Engineering and Chemical Engineering I am pleased to present my proposal, highlighting our extensive experience and proven track record in delivering exceptional results. Our portfolio of success will showcase past projects that demonstrate our ability to meet and exceed client expectations. Glowing testimonials from satisfied clients will attest to our professionalism, dedication, and the quality of our work Please note that the initial bid is an estimate, and the final quote will be provided after a thorough discussion of the project requirements or upon reviewing any detailed documentation you can share. Could you please share any available detailed documentation? I'm also open to further discussions to explore specific aspects of the project. Thanks Regards. Talha Ramzan
$10.000 USD in 14 Tagen
2,2
2,2

Hi Your project requires precise V and V execution with structured documentation suitable for regulatory submission. While my primary background is in software systems and testing automation, I have experience supporting technical validation workflows, BLE protocol testing frameworks, and structured test reporting that aligns with regulated environments. I can assist by building and executing the BLE command test harness, developing automated logging for FiO2 telemetry and system state data, and structuring the V and V documentation so the results are cleanly traceable for IRB or future FDA submission packages. My approach focuses on reproducible testing, clear validation logs, and organized reporting that aligns with engineering and regulatory expectations. If the physical measurement portion is handled on site with the oxygen analyzer and flow equipment, I can ensure the BLE protocol validation, command testing, safety behavior simulations, and documentation pipeline are executed thoroughly and efficiently during the testing window. I am available to begin planning immediately so the testing workflow is ready for the mid April schedule. Best, Justin
$15.000 USD in 7 Tagen
0,0
0,0

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