What You'll Do:
- Including, but not limited to:
- Provide quality engineering support for manufacturing operations (in-house and contract manufacturing).
- Partner with Manufacturing to establish and maintain robust in-process and final inspection criteria.
- Support process validation activities (IQ/OQ/PQ) and ensure compliance with ISO 13485 and FDA 21 CFR Part 820 requirements.
- Aid in production ramp-up and collaborate cross-functionally to address issues and drive continuous improvement projects.
- Develop and maintain the supplier quality program, including supplier selection, audits, and ongoing performance monitoring.
- Collaborate with Product Development and Manufacturing functions to qualify new suppliers and components.
- Manage supplier non-conformances and corrective actions to ensure timely and effective resolution.
- Ensure compliance with design control requirements (21 CFR 820.30, ISO 13485, ISO14971).
- Author, review, and approve design control documentation (Design History File, risk management files, verification/validation protocols and reports).
- Support design transfer activities to manufacturing.
- Collaborate with cross functional teams to ensure design and manufacturing changes are assessed and implemented according to applicable regulations.
- Champion for quality initiatives and improvements.
- Performs gap assessment of external standards.
- Lead root cause investigations and implement effective corrective and preventive actions (CAPAs).
- Support internal and external audits.
- Supports regulatory submissions as needed.
Required Skills & Experience:
- 7+ 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
Bonus Points For:
- Technical knowledge of electromechanical systems and software medical devices
- ASQ CQE, or related certification a plus.
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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