Senior Electrical Design Engineer

1 week ago

Westfield, Massachusetts, United States Oxenham Group Full time
Job Title: Senior Electrical Design Engineer

We are seeking a highly skilled Senior Electrical Design Engineer to join our team in Westfield, Indiana. As a key member of our manufacturing team, you will be responsible for designing and developing implantable-grade electronics for Class III medical devices.

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.

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