Senior Electrical Design Engineer
Oxenham Group
Full-time
On-site
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.
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.