Join our Team

/ Career Opportunity

Product Safety and EMC Engineer

Join the Biotex electrical safety team and help ensure the safety and effectiveness of the next generation of high-end, user friendly, and energy efficient medical devices. We maintain a dedicated electrical safety testing laboratory complete with sate of the art power supplies, electronic loads, and thermal chambers to meet all of our testing needs. As a Produce Safety and EMC Engineer, you will be vital to maintaining and improving our electrical safety testing services.

Primary Job Functions

• Facilitate a systems-level approach to Safety and EMC compliance for new product development and existing product by collaborating with Biotex, Inc. Product Development engineering as needed.
• Write Safety/EMC Test Plans and Reports based on IEC 60601-1 and IEC 60601-1-2.
• Able to set up Safety and EMC test equipment and write/maintain equipment operating procedures.
• Perform and/or provide guidance on Safety and EMC testing as required by IEC 60601-1 and IEC 60601-1-2. Provide guidance to Safety/EMC test technician as required.
• Perform troubleshooting of test equipment and equipment under test as needed and communicate any EUT performance issues as they occur.
• Perform EMC/Safety assessments for proposed design changes and provide design recommendations to R&D engineers and management.

Secondary Job Functions

• Set up and run on-site environmental chambers as needed, according to pre-approved test protocols.

General

• Completes professional level engineering assignments related to Product Safety and EMC. Leads and participates in projects involving the design, fabrication, and manufacture of complex medical subassemblies, systems or processes.
• Responsible for implementing and maintaining the effectiveness of the Safety/EMC quality system.
• Perform Safety/EMC Assessments and provide design recommendations to R&D engineers and managers.
• Interact with external certifying agencies during the creation and maintenance of Safety/EMC Files and CE Marking Technical Files.
• Travel as necessary to aid in program facilitation or for training (10%).

Expected Skills/Attributes

• A proven self-starter with the highest level of integrity in the successful completion of your work.
• Strong technical background and knowledge of the Product Safety and EMC testing procedures/standards.
• Advanced organizational skills and attention to detail.
• Excellent oral and written communication and documentation skills.
• Pro-active problem-solving skills.
• The ability to work co-operatively and effectively with others to establish and maintain good working relationships.
• Must be able to collaborate with multi-disciplinary groups and functions on site.
• Effectively interface with external certification agencies.
• Familiarity with Safety/EMC test equipment and methods, and general laboratory test equipment.
• Ability to adapt and work in an FDA regulated environment.
• Knowledge of regulations and standards affecting the medical device industry is a plus.

Minimum Qualifications

• Bachelor’s degree in an Engineering or closely related discipline with five or more years work experience.

Preferred Qualifications

• Bachelor’s Degree in Electrical, Mechanical, or Biomedical Engineering with a minimum of 5 years work experience in medical Product Safety and EMC testing.

/ 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.