The Manufacturing Engineering Mechanical Technician is structured under manufacturing engineering and is responsible for supporting the hardware 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.

Duties and Responsibilities

  • Actively involved with the mechanical assembly of new designs and prototypes
  • Strong hands-on skills and dexterity to assemble small delicate, complex, and precision components under a microscope
  • Strong skills performing fluid and gas flow testing on micro-devices
  • Ability to read and interpret technical documentation, including drawings, procedures, schematics, etc.
  • Assists with the evaluation, development, and validation of new processes
  • Continually refines processes and updates corresponding documentation
  • Work collaboratively with, support, and demonstrate respect for manufacturing assemblers and technicians
  • Participates in verification and validations (V&V) efforts, including building test samples & test setups, conducting testing, reporting, qualifications etc.
  • Perform line clearance (e.g. cleaning and sanitizing workstations at the start/end of shift and when transitioning to next WOs)
  • 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
  • Experience assembling precision electro-mechanical devices under a stereoscope using tweezers and vacuum pickup tools
  • 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: laser welder, autoclave, ultrasonic cleaner, flow meters, precision balances, pressure and vacuum regulators, He leak detector, pressure decay leak detector, microscope, soldering, gluing, precision fixtures/tools, ovens, 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)

Education and Experience Requirements

  • Experience: 5-8 years or related word
  • Education: High School Diploma or equivalent
  • Prior Class III medical device manufacturing experience is preferred
  • Working knowledge of management quality system requirements for medical devices
  • (ISO 13485:2016, ISO 14971:2019, (EU) 2017/745, FDA 21 CFR 820)
  • PC and knowledge of appropriate software (e.g. MS Word, Excel, eQMS, and ERP
  • software)

Working Conditions

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