Foundry Medical Innovations featured at the 10x Medical Device Conference

Foundry Medical Innovations is excited about the 10x Medical Device Conference coming up! Now in its 3rd year, 10x is the thought leaders forum for medical device executives and the annual meeting for the Medical Devices Group, the world’s largest medical device community. Over 125 companies will be present at the conference creating an excellent opportunity for networking and discussion. For many, the conference is about new ideas. For others, it’s about new business. Our very own, Meghan Alonso, the leader of the Medical Device group in the Southern California region is organizing the event along with the host, Joe Hage. Along with Meghan is Abby Alonso, Meghan’s 2 year old husky, will direct the welcoming committee! We encourage you to learn more about the Medical Device group, and consider attending the conference as well. Click here to sign up today! Use discount code: Alliance for $25 off.

 

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Foundry Medical is Hiring!

As we continue to grow to serve more customers, we have more opportunities for employment. Currently, we are looking for a Senior Product Development Engineer and a Clinical Research Associate. Check out the job description below and see if you have what it takes to join our team! Apply by sending your resume and cover letter to info@foundrymed.com

Senior Product Development Engineer

Job description

The Sr. Product Development Engineer will be a part of the Foundry Medical Innovations team.  They will serve as leader on some projects and assist with others.  This position requires a high level of autonomy and communication directly with customers.   You will be asked to…

  • Instill trust in our customers through your dedicated effort to achieve their product development goals with speed and efficiency.
  • Develop creative and innovative design concepts and help turn them into reliable, cost effective and user friendly products.
  • Manage multiple development projects simultaneously.
  • Coordinate the entire development process, from concept through manufacturing transfer.
  • Maintain project schedules and budget.
  • Promote the values and ethics of our company through all interactions with potential collaborators, customers and vendors.
  • Help create a fun, rewarding and collaborative environment.

Desired Skills and Experience

  • 5+ years of medical product design experience preferably with high volume disposables.
  • Proficiency with Solidworks.
  • Fluidic Device Design:  Hands on experience with design and development of a wide variety of micro and mesofluidic devices.  Understanding of both prototyping and manufacturing methods for microfluidic device fabrication.
  • Thorough understanding of conceptual design, design refinement, rapid prototyping methods and design for high volume manufacturing
  • Understanding and application of instrument interface for fluidics disposables that are part of  system
  • Strong track record of applying engineering analysis to product design.
  • Excellent written and verbal communication skills.

Education:

  • Minimum of a Bachelor’s of Science degree in Mechanical, Biomedical, Microfluidics Engineering or similar

 

Clinical Research Associate

Job description

The Clinical Research Associate (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH/GCP, and all applicable regulatory requirements.  Occasional travel will be required.

Responsibilities:

  • Implement and monitor clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH/GCP guidelines
  • Assess the qualification of potential investigative sites, initiate clinical trials at investigative sites, instruct site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites
  • Review and verify accuracy of clinical trial data collected, either onsite or remotely Provides regular site status information to team members, trial management, and updates trial management tools
  • Complete monitoring activity documents as required by Foundry SOPs or other contractual obligations
  • Work closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
  • Perform essential document site file reconciliation. Perform source document verification and query resolution
  • Assess IP accountability, dispensation, and compliance at the investigative sites.
  • Communicate with investigative sites
  • Update applicable database systems
  • Ensure all required training is completed and documented
  • May be assigned additional Clinical Operations tasks
  • May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines
  • Promote the values and ethics of our company through all interactions with potential collaborators, customers and vendors.

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Desired Skills and Experience

  • BA or BS Degree required, preferably in a science discipline
  • Minimum of 1 to 3 years monitoring clinical trials (IVD preferred)
  • Ability to travel up to 2-3 nights per week with the possibility of occasional additional overnights
  • Ability to instill trust in our customers through your dedicated effort to achieve their goals with quality, speed and efficiency.

 

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