Biomedical Technician

Full time On-Site (Beverly, MA)

Compensation Range: $30-$33/hour depending on experience

As a Biomedical Technician, you’ll contribute significantly to the successful maintenance and development of the company's Quanta Dialysis System machine population, both internally and externally at our US Headquarters in Beverly, MA.

Quanta Dialysis Technologies is on a mission to make dialysis accessible to every patient in every setting with its innovative QD system. With its compact size, intuitive design and GUI interface, and proven performance, QDS offers a solution that delivers powerful clinical outcomes.

Key Responsibilities

• Build / Upgrade / Rework / Repair & Maintenance of Clinical & Development Machines
• Execution in compliance with specifications / drawings, Quality Management Systems (QMS) procedures and safety requirements.
• Machine testing and associated record keeping.
• Ensure quality record-keeping is complete and correct, including details of machine configuration and records of modifications, maintenance, and repairs through life.
• Support external manufacturing partners to develop their ability to build, test, fault- find and repair machines.
• Maintain segregation in accordance with procedures of clinical and non-clinical stock, equipment and identification of materials (including non-conforming materials).
  
  

Machine Fault-Finding

• Fault-finding and diagnostics.
• Identify and report observed and/or suspected issues.
• Support root cause identification.
• Support triaging and issue management process for resolution of problems.
• Support definition and execution of machine and sub-system tests (including functional, performance and safety).
  
  

Machine Field Support (Clinical Use)

• Support field deployment of machines to sites for clinical use.
• Support rectification of issues reported by users.
  
  

Machine Management Process & Infrastructure

• Enforce ESD controls and good workshop practices.
  
  

Requirements/Qualifications

• Qualified biomedical technician with a minimum of an associate degree or professional experience achieving similar competence in the discipline may be acceptable
• High level of aptitude and ability to learn new products and systems quickly
• Dialysis experience preferred.
• Experience of working to the requirements of a Quality Management System is desirable, compliant with relevant international standards (e.g. ISO 13485, FDA 21CFR820).
• Strong communication skills, both written and verbally.
• Proven ability to understand and communicate how machines work, based on conventional engineering specifications, drawings, design descriptions.
• Able to work with mechanical, electronic, pneumatic and fluidic technologies.
• Able to demonstrate mechanical skills by assembly/dis-assembly of components, subsystems and machines without damage.
• Able to demonstrate electrical/electronic skills through an ability to handle, insert and remove Printed Circuit Boards (PCB) and associated cabling without damage.
• Immaculate attention to detail, able to generate and maintain formal records in accordance with Good Documentation Practice, QMS procedures and company IT processes.
• Ability to lift 70 pounds short distances