The Manufacturing Engineering Electronics Technician is structured under manufacturing engineering and is responsible for supporting the electronics team though all stages of process and product development.  This includes hands-on activities for process feasibility, process development, product development, production and any other activities that pertain to the development and manufacturing of the Physiological Devices ThinPumpTM Artificial Pancreas.

TO APPLY: Send Resume/CV and Cover Letter explaining your fit with this position via email to: careers@physiologicdevices.com.

Responsibilities

  • Actively involved with the assembly of new designs and prototypes
  • Strong hands-on skills and dexterity to assemble small delicate & complex components under a microscope
  • Solder small electronics devices, modify, and repair PCB assemblies
  • Interface DAQs and I/O controls with PC, write simple code, automate data gathering
  • Ability to read and interpret technical documentation, including drawings, procedures, schematics, etc.
  • Assists with the evaluation, development, and validation of new processes
  • Work collaboratively with, support, and demonstrate respect for manufacturing assemblers and technicians
  • Continually refines processes and updates corresponding documentation
  • Participates in electronics and software verification and validations (V&V) efforts, including building test samples & test setups, conducting testing, data collection, reporting, qualifications etc.
  • Ensure all required components and tools are ready for the builds
  • Perform bench testing and reports as needed
  • Routinely engage with engineers and other members of the technical staff to ensure work meets specification
  • Strong documentation skills, including plans, reports, lab notebooks, emails, etc.
  • Ability to work in an ISO Class 7 clean room
  • Review, follow, and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records (DHR)
  • Familiar with GMP and GDP best practices, and their application to support company policies, procedures, and objectives
  • Ability to lead and train junior technicians as the company grows
  • Supports company Quality Management System (QMS) and Quality Policy procedures, including routine trainings, material/process/equipment controls, CAPA/NCMR/SCAR, etc.
  • Initiates discussions for any potential concerns with product quality
  • Self-starter and motivated to accomplish company goals and milestones
  • Ability to work independently on tasks as well as in team settings as needed
  • Performs work in a safe and efficient manner

Qualifications

  • Experience working in compliance with Medical Device QMS
  • IPC-A-610 certification is preferred
  • Strong written and verbal communication skills
  • Collaboration skills – must be able to work closely with assemblers, technicians, and engineers
  • Comfortable with lab environment and equipment not limited to: microscope, soldering, fixtures/tools, oscilloscope, voltmeter, signal generator, power supplies, etc.
  • Familiar with engineering materials (plastics, metals, chemicals, etc.) related to medical device manufacturing
  • Ability to read, write, and follow technical documents
  • Strong computer knowledge and skills, especially with Microsoft office products (e.g. Word, Excel, Outlook)

Working Conditions

  • Manufacturing floor
  • Clean room
  • R&D lab
  • Warehouse
  • Office

Physical Requirements

  • Must be able to physically move materials up to 50 lbs as needed
  • Must be able to work in a clean room