Senior Electrical Engineer II

2 weeks ago

Houston, United States Biotex Inc Full time

Company Description

Biotex is a Houston-based company specializing in the development, launch, and manufacturing of medical and bio-technologies. As a registered FDA manufacturer, we partner with entrepreneurs, start-ups, and established companies to bring concepts to life through our comprehensive medical device development and manufacturing capabilities. With a pipeline of novel medical technologies at various stages of development, Biotex is committed to innovating and solving complex problems in the medical, biomedical, and bio-technology fields.


Role Description

This is a full-time, on-site role for a Senior Electrical Engineer at Biotex Inc. The Senior Electrical Engineer will be responsible for designing, developing, prototyping and testing all aspects of electrical components, systems, and products from design concept to manufacturing release. The role will involve collaborating with cross-functional teams to ensure the successful implementation of electrical designs and systems.


Essential Duties

  • Design, develop, prototype and test all aspects of electrical components, systems, and products including the assembly and part drawings as well as other required documentation from design concept to manufacturing release
  • Engineering analysis, design, design assurance and sustaining responsibilities for medical device electronic hardware, principally in the area of analog, digital, embedded controls, interfacing and power systems integration of Class II and III active medical devices
  • Develop concepts for next-generation medical device, and demonstration of these concepts through prototype design, laboratory testing and pre-clinical tests
  • Lead the identification and execution of medical device engineering projects, including the planning (task, schedule, and budget), execution and reporting of the associated activities and milestones
  • Perform or lead bench testing, design verification and validation activities, including associated documentation and records of new medical devices and expansion of existing products.
  • Participate in all aspects of medical device product design including specifications development, architecture design, schematic capture and layout, hardware selection processes, PCB assembly, risk analysis, test method development, and design reviews as project leader, participant and independent reviewer, as applicable
  • Develop, evaluate, and/or select new design methodologies and technologies that drive development of new generation of medical devices as well as support current ones
  • Develop engineering changes and engineering drawings with minimal design requirements and instructions
  • Create document packages that specify the complete design intent of a product, including drawings, Bill of Materials and Engineering Change Orders
  • Interface with program management; provide oral and written high quality status updates and meet commitments
  • Serve as client liaison and/or team leader to provide support and direction to an assigned team including facilitating team and client communications as well as project budget adherence including planned corrective actions as needed.
  • Manage and support improvement activities in conformance with established programs and objectives per the Quality Management System.
  • Responsible for the performance appraisal, development, and training of engineers


Minimum Education, Skills and Experience Required

  • BS in Electrical Engineering (MS preferred).
  • Minimum of 8 years of professional, scientific and/or biotechnology project management experience with mandatory experience in device development.
  • Strong computer skills including the MS Office suite and MS Project.
  • Proven track record of system engineering on complex hardware systems. Demonstrated ability to interpret technical drawings, blueprints, specifications, illustrations and written documents.
  • Experience designing and building low-power miniaturized analog and digital systems.
  • Experience managing noise and maintaining signal integrity.
  • Prior experience integrating Bluetooth, Bluetooth LE, WiFi, and NFC, for data communication.
  • Expert at schematic capture, layout (Altium Designer preferred), and Design for Assembly/Manufacturing.
  • Experience designing PCB assembly test fixtures, test methods, and design verification plans.
  • Experience with programming languages such as C, MATLAB, and LabVIEW
  • Demonstrated experience as a self-starter and a fast learner; must work efficiently responding to changing priorities with minimal disruption, able to work independently and within a team; must have excellent problem-solving skills, analytical skills, research skills and attention to details.
  • Must be able to consistently meet deadlines, manage projects across several collaborators and handle multiple projects simultaneously.
  • Excellent written and verbal communication skills are required and must be able to write clear reports, proposals, etc., and efficiently discuss the same with other scientists, engineers, and customers.


Additional Desirable Skills

  • Prior experience with flex circuits preferred.
  • Experience working with OEM, contract manufacturers, and contract designers
  • A successful track record in implementing medical devices leading to FDA or CE product clearance.
  • Experience with device approval process (e.g., 510K application, De Novo application).
  • Experience with biometric and physiological sensors
  • Experience with medical product development under ISO 13485, ISO 14971, ISO 62304, ISO 60601 and FDA QMSR
  • Experience with Jira, Bitbucket, and/or Confluence


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