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: firstname.lastname@example.org.
- 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
- 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)
- Manufacturing floor
- Clean room
- R&D lab
- Must be able to physically move materials up to 50 lbs as needed
- Must be able to work in a clean room