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
Top Skills
What We Do
Avive Solutions, Inc. 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.
Despite tackling a massive and complex public health issue, which has had the same dismal survival rate of 10% for decades, Avive does so with optimism and fervor. Fueled by the words and experiences of those whose lives have been impacted or lost to SCA, the Avive team has simply refused to accept the status quo, working relentlessly to move the needle on survival rates.
Rory Beyer, Moseley Andrews, and Sameer Jafri came together with a seemingly simple idea – that anyone can and should be able to positively impact the outcome of a Sudden Cardiac Arrest (SCA) rescue.
Drawn together by their complementary skills and background, they met at a conference focused on SCA prevention and quickly came to share a vision for the profound impact that a more effective solution could have on thousands of families every year.
With Rory and Moseley’s technical expertise and a novel AED concept they had developed at MIT, combined with Sameer’s experience in SCA prevention through his non-profit organization – Saving Hearts Foundation, the three co-founded Avive in 2017.
Our story is just beginning, and we hope you’ll come write it with us.
https://youtu.be/XUiwcB_9bzw
We are actively hiring, see how you can contribute at https://avive.life/careers/
Why Work With Us
If you'd like to learn more about what it’s like to work at Avive, visit https://avive.life/careers/
And check out our Glassdoor reviews at:
https://www.glassdoor.com/Overview/Working-at-Avive-Solutions-EI_IE8305608.11,26.htm
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