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Electrical Quality Engineer

Paradromics

Paradromics

Other Engineering, Quality Assurance
Austin, TX, USA
Posted on Thursday, June 13, 2024
About Paradromics

We are building a direct data interface with the brain to provide technology solutions to unmet medical challenges. A revolutionary leap beyond today’s research-grade brain computer interfaces (BCI), our Connexus® Direct Data Interface (DDI) collects neural signals at an industry-leading high data-rate and is designed for long-term daily use. Our first clinical application will enable severely motor-impaired people to communicate and independently use a computer, translating their neural signals into synthesized speech, text, and cursor control. We will continue to expand the capabilities of our massively scalable platform to support a pipeline of future applications that could benefit millions.

The Role

The Electrical Quality Engineer conducts Quality Engineering activities and collaborates with the EE department, aiding in the creation of design documentation and production controls for the system's entire signal chain, from custom circuits to implantable electronics and user interface software. Responsibilities include quality engineering support for design, simulation, PCB layout, system debugging, custom silicon testing, verification and validation activities, and production controls.

The role involves proactive involvement in the design, verification, and validation of electrical components and systems to ensure compliance with medical device industry standards and regulatory requirements. The ideal candidate will effectively bridge quality assurance and electrical engineering, driving quality throughout the design, production, and clinical phases, ensuring the delivery of robust, compliant, and high-performance products.

This position is instrumental in supporting the company’s continued growth and future success, and requires an individual with a “can-do,” self-starter attitude who is excited about working collaboratively and diving into hands-on, detailed work in an early-stage medical device company. This individual must be able to step back to view the bigger picture and understand where we are as a company to set priorities, strategy, and direction. This position is based on-site in Austin, Texas and will have less than 5% travel.

Responsibilities

  • Collaborate with electrical engineering teams from the initial design phase through to manufacturing, focusing on integrating quality regulations standards throughout the product lifecycle, specifically FDA 21 CFR 820, ISO 13485, and ISO 14708
  • Execute detailed Verification & Validation (V&V) processes for electrical components and systems, emphasizing safety, functionality and compliance to relevant standards and regulations.
  • Lead root cause analysis in response to product issues, implementing corrective and preventive actions to enhance product reliability and compliance.
  • Utilize Design of Experiments (DOE) methodologies to optimize electrical design processes, enhance product performance, and streamline development activities.
  • Conduct rigorous risk management activities, including FMEA, to identify and mitigate potential failure points in electrical designs.
  • Oversee quality control processes in manufacturing, ensuring adherence to specifications and regulatory standards.
  • Prepare and review documentation for regulatory submissions, ensuring all electrical engineering aspects are accurately represented and compliant.
  • Provide support and training to other team members regarding best practices in electrical quality assurance.
  • Maintain up-to-date knowledge of industry trends and advancements in medical device regulations and electrical engineering technologies.
  • Support the Quality department in creating systems, procedures and records to comply with 21 CFR 820 and ISO 13485.
  • Other duties as assigned

Required Education

  • Bachelor’s degree in Electrical Engineering, or related field

Required Qualifications

  • Minimum of 3 years of experience in the medical device industry, specifically with electrical engineering
  • Comprehensive understanding of relevant regulations and standards (FDA 21 CFR 820, ISO 13485, ISO 14708).
  • In-depth knowledge and hands-on experience with analog and digital electronics, including PCB design and layout (Altium preferred).
  • Proficient with advanced lab instruments such as oscilloscopes, spectrum analyzers, and logic analyzers.
  • Demonstrated ability to develop innovative solutions to complex technical and regulatory challenges, with a commitment to continuous learning and improvement.

Preferred Qualifications

  • Previous experience working in a high-growth startup environment.
  • Knowledge of and practical application of IEC 62304 and IEC 62366 requirements
  • Proficiency in Python for automation of test procedures and data analysis, complementing traditional electrical engineering skills.
  • Practical experience with real-time Linux programming environments, enhancing the capability to work closely with embedded systems in medical devices.
  • Proficient skills in statistical data analysis

Paradromics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.