Principal Electrical Design Engineer

About the Job

Portal Diabetes, Inc. has an exciting career opportunity for an experienced Principal Electrical Engineer/Designer. This role functions as the primary designer of implantable grade electronics for a Class III medical device and supports all aspects of electrical development from concept & design phases, through V&V, clinical trials, and into commercialization.

The Company

Our goal is to deliver a next generation implantable automated Insulin delivery pump that significantly improves the quality of life for users with Type 1 Diabetes. We are a small, fast paced company located in Westfield, Indiana.

Job Responsibilities

• Designs and generates PCBA layouts, schematics, and associated manufacturing files
• Develops and maintains energy use budget to ensure device meets its intended longevity.
• Develops electronics that can endure all manufacturing processes
• Develops acceptance tests for electronics in manufacturing.
• Participates in design reviews and risk assessments with the systems and company’s various stakeholders.
• Qualifies electronics, including PCBA & battery, from feasibility through V&V
• Specifies electronics requirements derived from system specifications and mitigations from risk assessment.
• Reviews electronics designs, firmware, and software design outputs
• Assists with troubleshooting electronics during manufacturing and testing.
• Assists with automating test systems on the manufacturing line as needed
• Reports directly to the Head of Engineering

Required Skills/Experience

• Minimum Education: BS in appropriate discipline from an accredited University
• Ten (10) years’ experience in 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