Staff Electrical Engineer - Oxenham Group LLC

Staff Electrical Engineer - Implantable Medical Devices

Our client is seeking an Electrical Engineer to serve as the lead designer for implantable-grade electronics used in Class III medical devices, supporting all stages of electrical development from concept design through verification & validation (V&V), clinical trials, and commercialization.

Key Responsibilities

• Design and maintain electronics for implantable devices, as well as supporting electronics for software and manufacturing testing.
• Create and generate PCBA layouts, schematics, and manufacturing files.
• Develop and manage the energy use budget to ensure the device meets its longevity targets.
• Collaborate with mechanical engineers to ensure the implant's formfactor electronics fit in intended space
• Design electronics that can withstand all manufacturing processes.
• Develop acceptance tests for electronics in manufacturing environments.
• Participate in design reviews and risk assessments with cross-functional teams and key stakeholders.
• Document the design and operation of electronics, providing supporting technical documentation.
• Qualify electronics components (e.g., PCBA, battery) from initial feasibility to V&V stages.
• Translate system specifications and risk mitigation strategies into electronics requirements.
• Review designs for electronics, firmware, and software, ensuring alignment with product requirements.
• Assist with troubleshooting and resolving electronics issues during manufacturing and testing.
• Specify, develop, program, and maintain testing and manufacturing spreadsheets as needed.
• Document and address electronics-related issues found during manufacturing, working closely with the engineering team to implement solutions.
• Support the automation of test systems for manufacturing lines as required.
• Work closely with assemblers, technicians, and manufacturing and quality engineers on the production floor.

Qualifications

• 7+ years of experience in digital and analog electronics for safety-critical systems.
• Experience working with electronics for Class II or Class III medical devices, or experience working with electronics in a regulated industry.
• Proficient in using Altium Designer for schematic capture and board layout.
• Familiarity with medical device quality management systems (QMS).
• Knowledge of design inputs, risk management, design outputs, production controls, V&V, manufacturing software validation, and regulatory compliance (NCMR, CAPA, Deviations).
• General programming experience (C++, C#, C, LabView, or Python) preferred.
• Ability to read and generate electrical schematics and layouts.
• Strong written and verbal communication skills.
• Collaborative team player able to work closely with assemblers and technicians.
• Ability to write and comprehend technical documents, specifications, protocols, and reports.

Education & Experience

• Bachelor's degree in Electrical Engineering or related field.
• Minimum 7 years of experience, with 2-4 years in a Senior or Principal Engineering role within a medical device company.
• In-depth knowledge of medical device regulatory standards (ISO 13485:2016, ISO 14971:2019, (EU) 2017/745, FDA 21 CFR 820).
• Proficient with MS Office, project management tools, eQMS, and ERP software.

This position is an onsite member of the manufacturing team located in Westfield, Indiana.