Sr Quality Development Engineer (F/M)
The International Diabetes Federation estimates at 415 million the number of people living with Diabetes - one in eleven! - and predicts that this number will grow and reach 642 million in 2040.
Glycemic control is an essential part of diabetes management, aiming to avoid short and long-term complications associated with the condition. Glycemic control must therefore be measured in a rigorous and reliable way on a daily basis, in order to support the multiple decision-making specific to the management of the condition and maintain blood sugar levels in the desired levels.
With the availability of continuous glucose monitoring systems, aiming to provide users continuous visibility on their blood sugar level to optimize their treatment and improve their quality of life, diabetes management is entering a new era. And despite recent advancements, current available products still have some important shortfalls in helping people living their life with diabetes, not the other way around. And this is at the core of Metronom Health’s mission and vision, consisting of developing and designing a new continuous glucose monitoring system, aiming at making diabetes a smaller part of life.
Our disruptive technology aims at providing people living with diabetes and those caring for them with an accurate, reliable, user friendly and affordable continuous glucose monitoring system. Our CGM (Continuous Glucose Monitoring) system aims at significantly reduce both the short-term and long-term health complications associated with uncontrolled or poorly managed blood glucose levels, whilst improving the day to day quality of life of people living with diabetes.
A first in Human proof on concept study has been completed successfully, and we are now fully engaged in the development of the commercial product, targeting a market release in Europe by 2021.
It's time to reinforce our californian team. We are currently looking for a talented
Sr Quality Development Engineer (F/M)
Metronom Health is developing the next generation Continuous Glucose Monitor (CGM) with a new optics-based technology. We are excited to identify a Quality Professional that wants to join a fast-paced start-up environment. This person needs to be passionate about quality in a development environment and looking for their next challenge.
- Support and monitor new product development for adherence to the internal quality management design control system and all ISO, FDA and QSR regulations.
- Provide regulatory compliance input to the Operations team on quality issues arising during process improvements and risk updates.
- Manage pre-production design assurance/quality engineering activities as they relate to product lifecycle development.
- Participate in formal design reviews, ensuring design control requirements are met during each design phase.
- Review and approve verification and validation protocols and reports for completeness and accuracy.
- Work with supplier quality and supply chain groups to ensure product suppliers are effectively developed.
- Verify Configuration Management and Risk Analysis records are properly addressed, accurate, and maintained.
- Ensure design changes are processed in accordance with current change-control requirements.
- Complete assigned tasks on schedule and identify and propose resolution for issues that may affect the timeline for remediation activities.
- Provide quality engineering support for nonconformance investigations as required.
- Coordinate the resolution of potential quality assurance deficiencies discovered during the product realization process.
- Support CAPA investigations, reviews, approvals, and/or CAPA plan implementations as required.
- Support DHF remediation for legacy and acquired DHF’s to comply with MDR.
- The Quality Engineer (QE) will be focusing on developing process along with Manufacturing Team.
- Engage with Suppliers in developing process and documentation of efforts.
- Develops inspection routines for new processes.
- Lead teams in PFMEA and DFMEA analysis.
- Medical Device experience is required
- Minimum of 5 years' experience in Quality is required
- Should have experience with programing automated inspection vision systems
- Experienced in performing test method validation and Gage R&Rs
- Must be able to work effectively and collaborate within cross functional teams
- Must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel
- Must have strong documentation skills
- Must take initiative and have the ability to conduct hands-on work
- Must possess the ability to handle multiple tasks with high attention to detail
- Quality engineering experience in new product development is preferred
A Bachelor of Science degree in Mechanical, Biomedical, or equivalent technical degree is required
If you are passionate and looking for a challenge, contact us and let’s discuss!