Join our Team

/ Career Opportunity

Electrical Engineer

Join BioTex product development team & help develop the electrical systems for the next generation of high-end, user friendly, & energy efficient medical devices. We utilize the latest techniques in electronics and software development such as Agile, Continuous Integration, and Testing Automation to the embedded and desktop software field. Every day, we push ourselves to find innovative solutions, produce higher quality products, and deliver them on schedule.

Roles and Responsibilities:

• Design cutting edge microprocessor based medical systems.with various sensor and optical technologies.
• Develop products in compliance with Design Control requirements
• Design and support Manufacturing and Quality for current products
• Perform or lead bench testing, design verification and validation activities, including associated documentation and records
• 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

Qualifications:

• The candidate must have at least a BSEE
• 3+ years electrical engineering experience
• Strong circuit design background with proven track record of producing quality, production ready designs
• Proficient in analog circuit theory, modeling and design
• Fluency with schematic, layout (preferably Altium) and simulation programs
• Experienced in battery powered designs.
• Strong Analytical approach to problem solving
• Proficient in firmware design
• Experience with SPI, UART, RS232, I2C, TCP/IP, BLE protocols
• Excellent communication and documentation skills.
• Ability to architect new systems
• Knowledge of IEC 60601

/ Career Opportunity

Software Engineer

Join Biotex product development team & help develop the exciting software applications for the next generation of high-end, user friendly, & energy efficient medical devices. We utilize the latest techniques in software development such as Agile, Continuous Integration, and Testing Automation to the mobile, desktop software and AI fields. Every day, we push ourselves to find innovative solutions, produce higher quality code, and deliver it on schedule.

Roles and Responsibilities:

• Design, develop and unit test modern desktop and mobile software within an agile development framework
• Communicate advanced ML/AI concepts to senior leadership to facilitate decision making
• Initiate new or revised documentation and tracks through appropriate approval cycles and implementation.
• Develop features for new generation of medical devices as well as supporting current ones
• Interface with other team members to build an integrated solution
• Interface with program management; provide oral and written high quality status updates and meet commitments
• Understand and follow company procedures and regulatory requirements
• Prepare and submit for approval requests for project funding. Participate in project planning, budgeting, scheduling and tracking

Qualifications:

• Minimum of 3 years of desktop, mobile and AI software development.
• Candidates with less than 3 years of combined embedded and desktop/mobile software development experience will be rejected.
• Experience in Computer Science fundamentals: object-oriented design, data structures, algorithm design, problem solving, and complexity analysis
• Experience developing and implementing machine- and deep-learning algorithms
• Proficient in C, C#, JAVA, and WPF
• Motivated, independent, efficient and able to handle several projects at once
• Attention to detail, and able to generate legible and clear documentation
• Ability to debug complex system-level problems
• Strong interpersonal skills and experience as part of a collaborative development team
• Strong problem solving, hands-on debugging, lab skills and use of test equipment
• Highly motivated and can achieve goals with minimal supervision
• Ability to interact with other disciplines such as hardware design, firmware development, OS Drivers and management software
• BS or MS degree in Computer Engineering, Electrical Engineering or Computer Science
• Experience with the agile software development process
• Proficient in distributed version control software systems such as Git etc.

/ Career Opportunity

Embedded and Desktop Software Engineer (Medical Devices)

Join the Biotex product development team & help develop the embedded controls for the next generation of high-end, user friendly, & energy efficient medical devices. We utilize the latest techniques in software development such as Agile, Continuous Integration, and Testing Automation to the embedded and desktop software field. Every day, we push ourselves to find innovative solutions, produce higher quality code, and deliver it on schedule.

Roles and Responsibilities:

• Design, develop and unit test high quality firmware within an agile development framework
• Design, develop and unit test modern desktop and mobile software within an agile development framework
• Initiate new or revised documentation and tracks through appropriate approval cycles and implementation.
• Develop features for new generation of medical devices as well as supporting current ones
• Interface with other team members to build an integrated solution
• Proficient in all storage techniques
• Interface with program management; provide oral and written high quality status updates and meet commitments
• Understand and follow company procedures and regulatory requirements
• Prepare and submit for approval requests for project funding. Participate in project planning, budgeting, scheduling and tracking

Requirements

• Minimum of 5 years of embedded firmware development or similar.
• Minimum of 3 years of desktop and mobile software development.
• Candidates with less than 5 years of combined embedded and desktop/mobile software development experience will be rejected.
• Experience in Computer Science fundamentals: object-oriented design, data structures, algorithm design, problem solving, and complexity analysis
• Proficient in embedded C
• Experience with 8/32 bit microcontroller firmware development with GNU tools
• Motivated, independent, efficient and able to handle several projects at once
• Attention to detail, and able to generate legible and clear documentation
• Proficient in C# and WPF.
• Ability to debug complex system-level problems
• Strong interpersonal skills and experience as part of a collaborative development team
• Strong problem solving, hands-on debugging, lab skills and use of test equipment
• Highly motivated and can achieve goals with minimal supervision
• Ability to interact with other disciplines such as hardware design, firmware development, OS Drivers and management software
• BS or MS degree in Computer Engineering, Electrical Engineering or Computer Science
• Experience with the agile software development process
• Proficient in distributed version control software systems such as Git etc.

/ Career Opportunity

 Sr. Mechanical Engineer - Medical Devices

We are seeking a highly motivated Mechanical Engineer with extensive catheter design experience to join our cross-functional team. Responsibilities include helping in research, design and development of innovative medical devices. The ideal candidate will need to demonstrate good knowledge of engineering and industry standards, as well as good writing and communication skills. A minimum of five years of related experience in the medical device industry is required.

Essential Functions

• Design and develop catheter products and components including, but not limited to, catheter balloon design, and multi-lumen channel design
• Drive the catheter product development process from initial prototypes through commercialization
• Define product requirements and component specifications
• Design and development of tooling
• Perform experiments to determine validity of designs
• Establish processes and manufacturing documentation for new catheter product pilot manufacturing lines,
• Design verification, process qualifications, equipment installations, and product and process validations.
• Identify processes to fabricate new products
• Review existing patents to determine infringement status as well as generate new IP during the course of development projects
• Develop, oversee, and interpret tests to verify product integrity in the design phase
• Gather input from clinical, marketing, literature and other internal and external sources
• Prepare product documentation including DHF, drawings, BOM, test protocols and reports, DCOs, etc.
• Advise team members as necessary
• Comply with applicable FDA and international regulatory laws/standards
• Assist in the transfer of newly developed products from R&D to production
• Other duties as assigned or required

Qualifications

• Bachelor’s and/or Master’s degree in Engineering required.
• Minimum of 5 years experience developing medical devices with 3 years experience in the development of catheters.
• Individual must have solid technical and mechanical ability, skills, process knowledge, and multiple (thermoplastic) catheter platforms experience.
• Experience with medical device R&D from concept to commercialization preferred
• CAD experience in SolidWorks is preferred.
• Thorough understanding of FDA and ISO 13485 Quality Systems Regulations.
• Strong written and oral communication and interpersonal skills are a must.
• Ability to work independently and to manage multiple tasks and projects in a fast-paced, changing environment is essential.

/ Career Opportunity

Development Engineer

Full-time research assistants. Qualified candidates will be degreed in engineering, laser-electro optics, or life sciences fields or have relevant experience in these fields. Preference will be given to candidates who have a background in laboratory or medical research environments. The ability to perform independent research and problem solving are also important.

/ Career Opportunity

QUALITY ASSURANCE ENGINEER

Join the Biotex team in delivering high-quality medical devices and design services to our clients. We maintain ISO 13485:2016 certification and develop devices to be distributed in domestic and international markets, compliant with regulations in those markets. As a Quality Engineer, you will be vital to maintaining and improving our Quality Management System.

Roles and Responsibilities

• Participate on design teams to ensure application of appropriate design and manufacturing controls.
• Provide quality representation to design control, design verification and validation, design transfer, process validation, risk management, and specification development on assigned product development teams to ensure compliance with Biotex policies and global regulations, including 21 CFR 820 and ISO 13485.
• Under supervision of the Quality Manager, advise project teams on compliance related to regulations, procedures, and requirements. Provide training, guidance and interpretation.
• Participate in technical discussions and risk-based decision making.
• Report status updates on assigned responsibilities and goals; escalate issues in a timely manner.
• Monitor equipment maintenance and calibration status, in conjunction with Operations.
• Assist in the process of addressing product non-conformances, including corrective and preventive actions where applicable.
• Contribute to the supplier selection process and monitor supplier performance.
• Approve documents that require Quality approval (at Quality Manager's discretion)
• Design test methods and review non-conformance records to assign disposition, root cause and need for corrective and preventive actions.

Qualifications

• Master's degree in a related field
• 0-2 years in quality-related industry
• Familiarity with FDA regulations and ISO 13485 preferred
• Ability to understand, apply, communicate, and think systematically
• Clearly express ideas in written communication, preferably with experience writing technical documentation