Full-Time

Senior Quality Engineer

Posted on 9/30/2025

Avive

Avive

51-200 employees

Sells AED devices with rechargeable batteries

Compensation Overview

$140k - $160k/yr

San Bruno, CA, USA

Hybrid

Category
QA & Testing (1)
Required Skills
Risk Management
Requirements
  • 5+ years of quality or manufacturing engineering experience in medical devices
  • BS in Engineering (preferably Electrical, Mechanical or Biomedical)
  • Strong knowledge of FDA QSR, ISO 13485, ISO 14971, and applicable IEC/ISO standards (e.g., IEC 60601)
  • Strong interpersonal, and communication skills
Responsibilities
  • Manufacturing Support: Provide quality engineering support for manufacturing operations (in-house and contract manufacturing).
  • Manufacturing Support: Partner with Manufacturing to establish and maintain robust in-process and final inspection criteria.
  • Manufacturing Support: Support process validation activities (IQ/OQ/PQ) and ensure compliance with ISO 13485 and FDA 21 CFR Part 820 requirements.
  • Manufacturing Support: Aid in production ramp-up and collaborate cross-functionally to address issues and drive continuous improvement projects.
  • Supplier Quality: Develop and maintain the supplier quality program, including supplier selection, audits, and ongoing performance monitoring.
  • Supplier Quality: Collaborate with Product Development and Manufacturing functions to qualify new suppliers and components.
  • Supplier Quality: Manage supplier non-conformances and corrective actions to ensure timely and effective resolution.
  • Design Control & Product Development: Ensure compliance with design control requirements (21 CFR 820.30, ISO 13485, ISO14971).
  • Design Control & Product Development: Author, review, and approve design control documentation (Design History File, risk management files, verification/validation protocols and reports).
  • Design Control & Product Development: Support design transfer activities to manufacturing.
  • Design Control & Product Development: Collaborate with cross functional teams to ensure design and manufacturing changes are assessed and implemented according to applicable regulations.
  • General Quality Systems & Leadership: Champion for quality initiatives and improvements.
  • General Quality Systems & Leadership: Performs gap assessment of external standards.
  • General Quality Systems & Leadership: Lead root cause investigations and implement effective corrective and preventive actions (CAPAs).
  • General Quality Systems & Leadership: Support internal and external audits.
  • General Quality Systems & Leadership: Supports regulatory submissions as needed.
Desired Qualifications
  • Technical knowledge of electromechanical systems and software medical devices
  • ASQ CQE, or related certification a plus.

Avive is a medical technology company that makes automated external defibrillators (AEDs) designed to save lives during sudden cardiac arrest. Its AED devices feature rechargeable batteries that never need replacement, aiming to lower long-term costs for users. Avive sells AED units and accessories directly to a wide range of customers, including homeowners, businesses, and community organizations, and it provides guides and resources to help people choose and use the devices. The company emphasizes strategic, data-driven placement of AEDs and runs extensive community training programs to improve readiness and response in emergencies. Its goal is to make AEDs affordable, easy to access, and simple to use for everyone, thereby increasing the likelihood of survival from SCA.

Company Size

51-200

Company Stage

Late Stage VC

Total Funding

$97M

Headquarters

Brisbane, California

Founded

2017

Simplify Jobs

Simplify's Take

What believers are saying

  • 4 Minute Community program expanding across municipalities with 320+ AED deployments underway.
  • Strategic partnerships with NCHSAA, ATEPi, and Academy Safe unlock high-risk athletic markets.
  • Survival rates improve 7-10% per minute with early defibrillation; Avive bridges critical response gap.

What critics are saying

  • Philips and Medtronic bundle connected features into existing hospital contracts, commoditizing Avive's advantage.
  • RapidSOS platform disruption or acquisition eliminates 911 integration, Avive's core differentiator.
  • Failed 911 integration during cardiac arrest triggers class-action litigation and regulatory investigation.

What makes Avive unique

  • Connected AED with 911 integration via QuickRescue transmits real-time ECG and location data.
  • Rechargeable battery eliminates costly pad cartridge replacements, reducing total cost of ownership.
  • Lightest AED on market at 2.1 pounds with training mode for hands-on practice.

Help us improve and share your feedback! Did you find this helpful?

Benefits

Flexible Work Hours

Growth & Insights and Company News

Headcount

6 month growth

-3%

1 year growth

-3%

2 year growth

0%
PR Newswire
Feb 18th, 2026
North Augusta, South Carolina launches first 4 Minute Community program to combat cardiac arrest

North Augusta, South Carolina, has partnered with Avive Solutions to implement the 4 Minute Community Programme, becoming the first South Carolina city to adopt the initiative. The programme will strategically place 50 Avive Connect AEDs with CPR-trained volunteers to improve response to sudden cardiac arrest emergencies. The system enables 911 dispatchers to alert nearby citizen volunteers, known as CARE team members, who carry connected AEDs that integrate with emergency services via RapidSOS. When activated, the devices flash red screens and provide step-by-step instructions for CPR and defibrillation. With over 356,000 out-of-hospital cardiac arrests occurring annually in the US and a 90% fatality rate, the programme aims to deliver lifesaving therapy before first responders arrive, targeting the critical gap in emergency response time.

WBBJ-TV
Jan 21st, 2026
Avive Solutions hosts first Care Team Roundup event

Avive Solutions hosts first Care Team Roundup event. JACKSON, Tenn. - Avive Solutions and their '4 Minute Community' program hosted the first Care Team Roundup, Tuesday evening. There were two sessions both in the evening that talked about Avive's Intelligent AED device and how it can prevent sudden cardiac arrest. They also gave out awards for Care Team members who have responded to calls and also refresher courses on CPR. "The '4 Minute Community' program is designed for you neighbor to respond or some who is close to you in your neighborhood, in your area that you have a device. The device will alert you can accept the alert and you can go to the subject that's having the problem and apply the device and the device does the work," said Kevin Deaton, with EMS, West Tennessee Healthcare.

Avive
Dec 23rd, 2025
Avive teams up with ATEPi to advance athlete safety & Sudden Cardiac Arrest readiness

Avive teams up with ATEPi to advance athlete safety & Sudden Cardiac Arrest readiness. At Avive Solutions, its mission has always been to empower communities and professionals with the lifesaving tools to make a difference and improve survival from Sudden Cardiac Arrest (SCA). Avive Solutions, Inc is excited to now work alongside the Athletic Training Emergency Preparedness Institute (ATEPi), an organization dedicated to providing athletic trainers with the hands-on emergency responses skills they need to protect athletes during high intensity, time-sensitive medical emergencies. During Sudden Cardiac Arrest (SCA) incidents that occur during exercise or sporting events, athletic trainers are often the first first responders. The importance of training, AED equipment, and preparedness cannot be understated - not only for athlete safety, but for the safety of the spectators and community who attend athletic events. SCA is the most common cause of death for college athletes, and the number one cause of death on high school campuses, underscoring the importance of training and prevention efforts on campuses of all sizes. Avive is teaming up with ATEPi to help provide high-quality training for athletic trainers to help protect athletes at the high school, university, and professional sports levels. Founded just two years ago by Keith Owsley, MS, ATC, LAT, a former firefighter/paramedic and certified athletic trainer with over 35 years of experience, ATEPi is already making a big impact. Owsley saw a critical gap: while today's athletic training programs teach updated emergency competencies, many practicing athletic trainers graduated before new standards were introduced, and as they continue to be introduced. Through realistic, scenario-based workshops delivered in person, ATEPi ensures that trainers can master lifesaving skills where emergencies actually happen - on the field, court, or campus. In just two years, ATEPi has worked with healthcare groups as well as collegiate programs including the University of Memphis and Marquette University. ATEPi's reach extends into Major League Baseball, working with teams like the Milwaukee Brewers and Kansas City Royals during Spring Training. "Being in athletic training at various levels for years, I was well aware of the Avive Connect AED(R) and what it offers. It's a great device and has proven to be an excellent tool for us in our workshops training athletic trainers across all levels in emergency response. It's a great fully automatic AED device and we've had great responses from those who have used it. And having an AED trainer that can also serve as a fully functioning AED is a big bonus." By combining Avive's innovative Avive Connect AED(R) with ATEPi's commitment to high-quality, hands-on training, athletic trainers across all levels are better prepared to respond quickly and confidently when it matters most. Together, Avive Solutions, Inc is helping to save lives and protect the athletes, teams, and communities Avive Solutions, Inc serve. Have a question about the Avive Connect AED for your athletic facility or team?

Capital City CPR
Oct 30th, 2025
Our Community Showed Up Big: Inside Sacramento's CPR-A-THON

Its community showed up big: inside Sacramento's CPR-A-THON. On Thursday, October 16, Capital City CPR successfully trained nearly 300 people, at no cost, in hands-only CPR and AED for Sacramento's first-ever CPR-A-THON. The unforgettable twelve-hour event, hosted outside the State Capitol Building, brought the community together to learn critical skills, aimed at increasing survival rates from sudden cardiac arrest - because everyone deserves access to life-saving training. From 7:00 a.m. to 7:00 p.m., participants were able to drop in and receive hands-on training, led by its medically trained instructors and volunteers, where they were shown how to: * Identify sudden cardiac arrest * Administer hands-only chest compressions * Use an AED (Automated External Defibrillator) "I think it's really important for everyone, especially young people, to know hands-only CPR and how to use an AED because you just truly never know when, where, or who it could happen to... and when you're out at these events or just really anywhere in the public, you might be the only one who knows how to do CPR or use an AED. So, it's just really important to do your part in potentially saving the life of a loved one or a stranger," said Tiernen, one of the many EMT student volunteers who came out to support the event. In addition to non-stop, all-day CPR training, the CPR-A-THON also included a resource fair. Participants were able to talk to local vendors and community partners who were united around one goal - boosting Sacramento's cardiac arrest survival rates through education and action. * Avive Solutions, a company that creates its own accessible AED devices, provided twenty-five Avive Connect AED(R)'s, equipping participants with real tools and real-time practice to build the confidence and skills they would need in an emergency. * Ashcraft EMS, created by Ray Ashcraft, who provides study guides for EMT students, successfully handed out hundreds of units of Narcan to the community and educated them on the proper use and importance of the medication. "I'd love to see this medication on hand regularly for everyone. It's really, really critical in giving someone a fighting chance while EMS is on their way", said Jack with Ashcraft EMS. Community Donation In preparation for this event, Capital City CPR partnered with Avive Solutions to provide a free ~$2,000 Avive Connect AED(R) and free first aid/CPR training to the group that rallied the most participants. These essentials were donated to First Step Communities, a Sacramento non-profit organization that provides transitional housing and emergency shelter for unhoused community members. This donation ensures that lifesaving technology and education are available where it is needed most - helping protect some of Sacramento's most vulnerable residents. A special shout-out to its partners and twenty-plus volunteers who came together for the community, showing what's possible when passionate people unite over a common goal. The CPR-A-THON was just one of the many steps Capital City CPR has taken in helping the Sacramento community increase its survival rates for sudden cardiac arrest. Capital City CPR is recognized for its top-tier, comprehensive first aid training and courses, which provide its clients with the confidence and capability to respond effectively to a broad range of emergencies. For more information, visit Capital City CPR LLC. at capitalcitycpr.com and check out the courses Capital City CPR LLC. offer at capitalcitycpr.com/courses. Thank you again to everyone who worked to make this event a success and to the hundreds of people who showed up to learn how to protect their community. Capital City CPR LLC. hope to see you again next year!

Avive
Oct 24th, 2025
Building a Culture of Care - Highlights from the 1st Annual CPR-A-THON at the California State Capitol

Building a culture of care - highlights from the 1st annual CPR-A-THON at the California State Capitol. On Thursday October 16, 2025, Avive Solutions Inc., in proud partnership with Capital City CPR, hosted the inaugural CPR-A-THON, a community event that delivered 12 continuous hours of free, hands-on CPR and AED training on the lawn of the California State Capitol. The goal: to make life-saving education accessible to all and to foster a stronger, more prepared Sacramento. A powerful community effort. From 7 a.m. to 7 p.m., nearly 300 participants, ranging from students to public servants to everyday citizens, took part in sessions focused on hands-only CPR and AED use. Thanks to the generosity of dozens of volunteers, the event maintained consistent momentum throughout the day, drawing an enthusiastic crowd committed to learning lifesaving skills to help make their communities safer. To ensure every participant received meaningful, real-world experience, Avive provided 25 Avive Connect AED(R) s, giving learners the opportunity to train using actual defibrillators that displayed rescue graphics and played an audible CPR metronome. This hands-on exposure is a vital step toward increasing bystander confidence and readiness in emergency situations which require immediate action. Public health in action. Beyond CPR and AED training, the event also saw hundreds of units of Narcan distributed to the community - another critical tool in the fight against preventable deaths and time-sensitive medical emergencies. Collaboration was at the heart of the event's success, with support from: This cross-organizational teamwork highlighted what's possible when public health, emergency services, and the private sector come together for a common cause. Impact beyond the lawn. A notable moment during the CPR-A-THON was the donation of an Avive Connect AED and custom First Aid/CPR training to First Steps Communities, a nonprofit providing transitional housing for Sacramento's unhoused neighbors. This gesture reinforced the event's mission: ensuring that access to life-saving tools and education reaches all corners of the community. The event also served as an incredible opportunity for aspiring EMTs and public health professionals, many of whom volunteered their time and gained valuable hands-on experience and connections. Looking ahead. Avive Solutions, Inc extend its deepest gratitude to Capital City CPR, all participating agencies, and every single volunteer and learner who made this event a success. Sacramento has taken a meaningful step toward a future where more lives can be saved, and where preparedness becomes part of everyday life. Avive Solutions, Inc can't wait to build on this momentum next year. Until then, stay trained, stay ready, and keep the culture of care growing.

INACTIVE