Senior Balloon Development Engineer
Athens, TX
Job Type
Full-time
Description
Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech indus-tries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next-genera-tion solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.
At Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to Biomerics' values in all our interactions. It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here at Biomerics. We improve and advance the lives of our employees and the patients who depend on our products.
At Biomerics, we believe in integrity, partnership, empowerment and accountability, trust, agility, teamwork, and excellence, and we care. Our team-oriented, customer-fo-cused corporate culture prioritizes building strategic, mutually beneficial partnerships with customers and our team members.
We are seeking a highly skilled Senior Balloon Development Engineer to lead the design, development, testing, and manufacturing of high-performance medical balloons. This role requires expertise in assessing device applications, selecting appropriate materials, and developing robust manufacturing processes to meet customer requirements and regulatory standards. This position would interface directly with customers, design and development teams and engineers to develop and validate medical ballons to customers application and product specifications. The ideal candidate will have experience in medical balloon development, validation, testing, and tooling design, with a strong understanding of materials such as Nylon, Pebax, PET, and urethane. A background in plastics engineering is preferred but not required.
Responsibilities
Balloon Design & Development: Assess customer requirements and recommend materials and manufacturing processes to develop medical balloons.
Material Selection: Identify and evaluate materials (Nylon, Pebax, PET, urethane) to optimize performance and manufacturability.
Process Development & Validation: Establish, validate, and optimize processes and test data in compliance with FDA and ISO 13485 standards.
Balloon Testing: Develop and execute testing protocols to ensure product performance and reliability.
Tooling Design: Design and optimize tooling for balloon manufacturing processes; experience in this area is preferred.
Manufacturing Transfer: Support the transition of balloon designs and processes from development to full-scale production.
Regulatory Compliance: Ensure all processes and products meet required regulatory and quality standards.
Cross-Functional Collaboration: Work closely with customers, R D, quality, and manufacturing teams to achieve project objectives.
Requirements
Bachelor's degree in an engineering-related field (Plastics or Mechanical Engineering preferred).
Experience in balloon development, validation, and testing in a medical device or similar industry.
Knowledge of polymer materials such as Nylon, Pebax, PET, and urethane.
Tooling design experience is a strong plus.
Familiarity with FDA and ISO 13485 requirements for medical device development.
SolidWorks experience required.
Strong problem-solving skills and ability to work in a fast-paced environment.
Ability to produce timelines and project plans.
Revenue and expense tracking.
Preferred Skills:
Hands-on experience in medical balloon extrusion, blow molding, or thermal forming.
Direct experience with industry leading forming and testing equipment
Proficiency in CAD software for tooling design.
Experience with DOE (Design of Experiments) and statistical analysis for process validation.
Athens, TX
Job Type
Full-time
Description
Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech indus-tries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next-genera-tion solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.
At Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to Biomerics' values in all our interactions. It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here at Biomerics. We improve and advance the lives of our employees and the patients who depend on our products.
At Biomerics, we believe in integrity, partnership, empowerment and accountability, trust, agility, teamwork, and excellence, and we care. Our team-oriented, customer-fo-cused corporate culture prioritizes building strategic, mutually beneficial partnerships with customers and our team members.
We are seeking a highly skilled Senior Balloon Development Engineer to lead the design, development, testing, and manufacturing of high-performance medical balloons. This role requires expertise in assessing device applications, selecting appropriate materials, and developing robust manufacturing processes to meet customer requirements and regulatory standards. This position would interface directly with customers, design and development teams and engineers to develop and validate medical ballons to customers application and product specifications. The ideal candidate will have experience in medical balloon development, validation, testing, and tooling design, with a strong understanding of materials such as Nylon, Pebax, PET, and urethane. A background in plastics engineering is preferred but not required.
Responsibilities
Balloon Design & Development: Assess customer requirements and recommend materials and manufacturing processes to develop medical balloons.
Material Selection: Identify and evaluate materials (Nylon, Pebax, PET, urethane) to optimize performance and manufacturability.
Process Development & Validation: Establish, validate, and optimize processes and test data in compliance with FDA and ISO 13485 standards.
Balloon Testing: Develop and execute testing protocols to ensure product performance and reliability.
Tooling Design: Design and optimize tooling for balloon manufacturing processes; experience in this area is preferred.
Manufacturing Transfer: Support the transition of balloon designs and processes from development to full-scale production.
Regulatory Compliance: Ensure all processes and products meet required regulatory and quality standards.
Cross-Functional Collaboration: Work closely with customers, R D, quality, and manufacturing teams to achieve project objectives.
Requirements
Bachelor's degree in an engineering-related field (Plastics or Mechanical Engineering preferred).
Experience in balloon development, validation, and testing in a medical device or similar industry.
Knowledge of polymer materials such as Nylon, Pebax, PET, and urethane.
Tooling design experience is a strong plus.
Familiarity with FDA and ISO 13485 requirements for medical device development.
SolidWorks experience required.
Strong problem-solving skills and ability to work in a fast-paced environment.
Ability to produce timelines and project plans.
Revenue and expense tracking.
Preferred Skills:
Hands-on experience in medical balloon extrusion, blow molding, or thermal forming.
Direct experience with industry leading forming and testing equipment
Proficiency in CAD software for tooling design.
Experience with DOE (Design of Experiments) and statistical analysis for process validation.
Job ID: 484297979
Originally Posted on: 7/7/2025
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