Medical device V&V testing — need contract biomedical engineer in SF Bay Area for 4-6 weeks starting mid-April. Scope: FiO2 gas delivery characterization, BLE protocol testing, safety/failsafe verification, alarm testing. IEC 60601 experience required.
Budget: $10,000 – $20,000 USD
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.
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.
Related categories:
Engineering
Testing / QA
Electrical Engineering
Chemical Engineering
Biomedical Engineering