TOOLBOX MEDICAL INNOVATIONS IS EXPANDING TO BETTER SERVE OUR GROWING LIST OF CUSTOMERS

Skilled team members from several disciplines enjoy working at Toolbox Medical Innovations.  We are motivated by being a part of medical and diagnostic innovation to bring the next generation of healthcare to the world.  We enjoy working in a collaborative, team oriented environment that pushes solutions to existing healthcare problems wile advancing our careers and personal lives.

 

Does your mission align with ours?  If so we would like to hear from you.  Apply by sending your resume and cover letter to info@toolboxmed.com

 

Toolbox Medical Innovations Mission Statement:

Toolbox Medical Innovations is a medical and diagnostics device development firm specializing in design-for-manufacturing and clinical research.

We develop and conduct clinical research for class I, II, and III products across multiple disciplines with clients from all over the globe. We’re able to take your design from concept to manufacturing to clinical trials to successful product launch.

Our unique versatility allows us to provide turnkey product development, assist with design refinement, and work on a consulting basis. We offer a wide range of services from both our internal team, as well as a vast network of our collaborators, to ensure that you get the specific expertise and focus the market demands. Whatever the route, success is always our target.

 

OPEN POSITIONS:

Sr. Product Development Engineer

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

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.

.

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.