Principal Electrical Design Specialist

6 days ago


Indianapolis, Indiana, United States PHYSIOLOGIC DEVICES, INC. Full time

About the Opportunity

Physiologic Devices, Inc. is seeking an experienced Electrical Design Engineer to join our team. As a key member of our engineering department, you will be responsible for designing and developing implantable grade electronics for a Class III medical device.

The Company

We are a small, fast-paced company dedicated to delivering innovative medical solutions. Our goal is to develop a next-generation implantable automated insulin delivery pump that significantly improves the quality of life for users with Type 1 Diabetes.

Job Responsibilities

  • Design and develop PCBA layouts, schematics, and associated manufacturing files
  • Develop and maintain energy use budgets to ensure device meets its intended longevity
  • Develop electronics that can endure all manufacturing processes
  • Develop acceptance tests for electronics in manufacturing
  • Participate in design reviews and risk assessments with the systems and company's various stakeholders
  • Qualify electronics, including PCBA & battery, from feasibility through V&V
  • Specify electronics requirements derived from system specifications and mitigations from risk assessment
  • Review electronics designs, firmware, and software design outputs
  • Assist with troubleshooting electronics during manufacturing and testing
  • Assist with automating test systems on the manufacturing line as needed

Requirements

  • Minimum Education: BS in an appropriate discipline from an accredited University
  • Ten (10) years' experience in a related/regulated industry
  • 2-4 years of experience at a Senior or Principal Engineering position at a medical device company
  • Strong communication and interpersonal skills
  • Ability to self-start, work independently and collaboratively in a small team environment
  • Experience in using Altium Designer for schematics capture and board layout

Desirable Skills/Experience

  • Medical Device manufacturing experience highly desirable
  • Experience working with engineering teams (R&D, Manufacturing, Quality)
  • Experience with electronics in Class II or Class III medical devices
  • Experience working in compliance with Medical Device QMS
  • Experience in Design Inputs, Risk Management, Design Outputs, Production Controls, Verification and Validation, Manufacturing Software Validation, NCMR, CAPA, Deviations


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