Principal Electrical Design Specialist
6 days ago
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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