Sr Quality Test Engineer
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 Test 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 test methods and quality and looking for their next challenge.
Duties:
- The Quality Engineer (QE) will be focusing on test method development and validation.
- Manage equipment development and documentation
- In this role, it is expected that the Engineer works with R&D to understand design requirements and intended use of tests in the finished delivery system.
- The Engineer will work in a fast paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success.
- Manages test method development and validation projects.
- Tracks projects and keeps projects to a timely schedule.
- Develops test methods for various measurement applications
- Drafts, routes, reviews and approves inspection procedures, validation protocols and reports
- Coordinates test method validation activities
- Performs statistical analysis such as capability, gage R&R, and statistical process control
- Collaborates with R&D, Quality, Manufacturing and other functions on test method development and inspection-related issues
- Provides support for conceptualizing gage and inspection fixture designs. Creates fixture designs as needed.
- Develops inspection routines with measurement equipment and procures equipment appropriate for the method being developed.
- Lead technicians the execution of testing
Required Skills:
- Medical Device experience is required
- Minimum of 4 years' experience in Quality or Manufacturing is required
- Must be proficient with Creo or Solid Works
- 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
Education:
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!