Company:
Portal Diabetes, Inc.
Location: Westfield
Closing Date: 24/10/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
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
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Portal Diabetes, Inc.
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