Quality Engineer, Failure Analysis
Brisbane, CA
Quality & Ops /
Full-Time /
Hybrid
About Avive:
Avive Solutions, Inc. (https://avive.life) is a growth stage Automated External Defibrillator (AED) company with a connected response system that is rapidly gaining market share. We are a mission driven team that is quite literally saving lives. Sudden Cardiac Arrest (SCA) is a leading cause of death in the United States, and we are on a mission to change that! We are a dynamic organization that builds elegant, creative solutions to solve complex problems. Ultimately, our mission is for all cardiac arrest victims to have rapid access to life-saving defibrillation.
Avive is taking a fresh approach to addressing this decades-old problem by innovating AED technology, coupled with a first-of-its-kind software platform solution to enable a quicker and more streamlined response to SCA emergencies. We believe that this unique combination of deploying advanced – yet still accessible – hardware, and software, has the potential to revolutionize out-of-hospital cardiac arrest response and massively impact SCA survival rates.
Check out this short video that shows a glimpse of how our team is working to re-think cardiac arrest response and save lives!https://www.youtube.com/watch?v=2p4zfOWo62E
Learn more about working at Avive:https://avive.life/careers/
About the Role:
The Quality Engineer, Failure Analysis will be responsible for investigating complaints, internal non-conformances, and collaborating with various teams to ensure thorough investigations of product hardware and software issues. This role will be responsible for generating failure investigations reports, metrics and data analysis.
What You'll Do:
- Perform failure analysis on electromechanical devices returned with alleged malfunctions utilizing design documentation, system log data, software tools, manufacturing lot records, and lab / bench equipment.
- Generate complaint investigation reports, perform risk assessment and escalate any reportable and field safety issues.
- Investigate internal nonconformances of components, assemblies, and manufacturing processes.
- Collaborate with product development, software and manufacturing functions in analysis of product hardware and software failure modes.
- Work with Customer Success team on creating troubleshooting guides, customer follow ups and communications related to alleged complaints and customer feedback.
- Support development of methods and procedures for inspecting, testing and evaluating products.
- Generate monthly complaint and nonconformances metrics and data analysis.
- Support the quality processes for Management Review, Audits, CAPAs, and process improvements as needed.
Required Skills & Experience:
- 1 - 4 years of experience in engineering or technical role
- BS in Engineering (preferably Electrical or Biomedical)
- Excellent problem-solving skills, including demonstrated application of structured problem-solving methods and tools
- Strong interpersonal, and communication skills
Bonus Points For:
- Experience in electronics and devices with embedded software
- Experience of working in the Medical Device Industry
Equal Employment Opportunity
It is the policy of the company to provide equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, the company will provide reasonable accommodations for qualified individuals with disabilities.
NOTE: This Job Description in no way states or implies that these are the only duties or functions to be performed by the incumbent. Personnel are required to follow any other job-related instructions and to perform any other job-related duties/functions requested by their supervisor.
Anticipated salary range: $90,000 - $110,000
