Join our Team

/ Career Opportunity

 Senior Product Development Engineer

We are currently seeking a Senior Product Development Engineer to supplement our growing team. Candidates must have strong engineering experience and a passion for leading and managing product development programs using internal and contracted resources.

Roles and Responsibilities:

• Work with the leadership and staff to set direction for new and existing medical products.
• Lead new product development projects and provide technical support of existing products.
• Prepare and analyze design requirements based on user needs and intended use, usability and product application
• Take a strong, hands-on approach to engineering, problem solving and customer support.
• Create and maintain project schedules and budgets.
• Share technical expertise with others and help develop junior level engineers.
• Identify, qualify, and manage relationships with external partners and suppliers.
• Write and review Failure Mode and Effects Analysis activities for both Design and Process - FMEA's.
• Check part and assembly drawings, performs tolerance stack up analysis and implements GD&T on assembly and part drawings as necessary.
• Prepare and execute design verification, including writing test protocols and reports, reliability testing, traceability and safety testing per IEC 60601-1.
• Work to resolve quality issues and mitigate risk.
• Identifies product problems and leads their resolution.
• Manage existing product updates and upgrades.
• Practice good engineering design process: version control, lead design reviews, documented design history.
• Make decisions independently on engineering problems and methods, and represent the organization in client meetings, tradeshows, preclinical, and clinical studies.
• Complete projects within budgetary and scheduling goals.
• Ability to present in one-on-one and/or group settings.

Required Qualifications

• Master of Science degree in Mechanical/Biomedical Engineering or equivalent.
• At least six years of experience working in medical device design and product development.
• Candidates with no current or prior full-time professional experience in medical device industry will not be considered.
• Experience working with external design, development and manufacturing partners.
• Experience with the product development process ranging from requirements development, prototyping, verification and product release.
• Working knowledge of FDA CFR 21 820.30 design control requirements, ISO 14971 Risk Management (FMEA severity and probability), and European MDR requirements.
• Strong verbal and written communication skills.
• Proficiency in the use of PC and programs, particularly Excel, PowerPoint and Word.
• Ability to prioritize tasks.

Preferred Qualifications:

• Experience with IEC 60601-X.XX, ISO 13485, ISO 10993, and ISO 14971 standards.
• 5+ years of experience in mechanical and electromechanical component and assembly design, development and part release.
• Six Sigma knowledge and/or demonstrated practical statistics knowledge
• Familiarity with REACH and RoHS standards.
• Experience with silicone and/or plastic injection molding
• Practical experience in engineering of materials is necessary (Polymers, Metals, Composites and Engineered materials)

/ Career Opportunity

 Product Development Engineer

We are looking to hire highly motivated engineers for an entry level job in the medical device industry.

Roles and Responsibilities

• Develop a detailed understanding of medical devices developed and manufactured by Biotex.
• Rapidly develop an understanding of the Biotex ISO 13485:2016 documentation system procedures and requirements.
• Ensure that design engineering and production documentation is prepared and maintained consistent with cGMP and ISO 13485:2016 guidelines.
• Design, develop, prototype and test all aspects of mechanical, electrical and software components, systems, and products including the assembly and part drawings as well as other required documentation from design concept to manufacturing release
• Develop concepts for next-generation medical device, and demonstration of these concepts through prototype design, laboratory testing and pre-clinical tests.
• Prepare complex design layouts and/or schematics based on rough sketches or instructions from engineering personnel with some latitude for independent design judgment
• Assist with Installation, Operational, Performance Qualification and other related validation activities to bring operation of ISO Class 7 cleanroom.
• Develop engineering changes and engineering drawings with minimal design requirements and instructions
• Design concepts, manufacturing techniques, materials and manufacturing processes
• Create document packages that specify the complete design intent of a product, including drawings, Bill of Materials and Engineering Change Orders
• Implement documentation updates and changes to existing products
• Assist in medical device regulatory filings with the FDA, Health Canada and EU.
• Ensure product quality by designing and developing testing, verification and validation methods for production processes.

Required Qualifications

• Bachelor and/or Master's degree in Mechanical/Biomedical Engineering or equivalent.
• Strong verbal and written communication skills.
• Proficiency in the use of PC and programs, particularly Excel, Powerpoint, and Word.
• Ability to work independently and prioritize tasks.
• Experience with prototyping.

Preferred applicant requirements

• Experience with medical device R&D from concept to commercialization preferred
• Thorough understanding of FDA and ISO 13485 Quality Systems Regulations.

/ Career Opportunity

 Quality Assurance Engineer I

The Quality Assurance Engineer I is part of the Quality department and is responsible for ensuring quality in the development and manufacture of various medical devices. The Quality Assurance Engineer I will implement and refine the requirements of the Quality Management System, to include addressing nonconformances, investigating and implementing corrective actions, participating in process improvement initiatives, and ensuring that medical device development meets applicable requirements. Responsibilities also require the Quality Assurance Engineer I to engage with project managers, vendors, and internal/external stakeholders to exchange information and updates on Quality progress and compliance. This position reports to the Quality Assurance Manager.

Roles and Responsibilities

• Develop a detailed understanding of the medical devices developed and manufactured by Biotex.
• Rapidly develop an understanding of the Biotex ISO 13485:2016 documentation system, procedures, and requirements.
• Ensure that engineering, design, and production documentation is prepared and maintained consistent with cGMP, ISO 13485:2016, and other applicable regulatory guidelines.
• Evaluate and participate in the selection of suppliers by monitoring supplier performance
• Ensure containment (identification, segregation, and reconciliation) of nonconforming product to prevent unintended use.
• Implement documentation updates and changes to existing products.
• Ensure product quality by designing testing methods.
• Assist with documentation and validation activities of various new products under development.
• Review nonconformance records (internal and external) to determine disposition, root cause, and need for corrective and preventive actions.
• Identify and implement any changes necessary to ensure and maintain the continued suitability and effectiveness of the Quality Management System
• Evaluate the work environment in which product is manufactured, and ensure it is adequately environmentally controlled and monitored, with sufficient personnel and production safety controls.
• Maintain strong business relationships with key internal customers (such as Regulatory, Operations, and R&D), providing advice on relevant quality requirements for the company and its

Qualifications

• Bachelor's or Master’s degree in engineering, medical sciences, or other relevant field.
• At least 2 years related experience in Quality preferred (healthcare setting, medical device and/or pharmaceutical company and/or industry).
• Strong working knowledge of FDA QSR, ISO 13485, and EU MDR regulatory requirements.
• Demonstrate excellent written and verbal communication and collaboration skills in English.
• Strong organizational, planning, and follow-through skills.
• Able to work well under pressure and with tight schedules.
• High proficiency in Google Workspace, Microsoft Office, and in-depth knowledge of other presentation programs a plus.

/ Career Opportunity

 Compliance Engineer I (Criterion)

Criterion is the ISO 17025 accredited testing services department within Biotex, Inc., a premier medical device development and manufacturing company with more than twenty years of success in the industry. Criterion operates as an impartial testing authority to support in-house and external clients with compliance testing needs.

Roles and Responsibilities

• Perform multiple compliance-related tasks in various assignments, including designing, developing, and implementing testing methods and equipment.
• Demonstrate competence in a broader range of more complex tasks, specialized technical expertise in one or more areas relating to core Biotex services (electrical safety testing, EMC, sterile package testing, system testing, reliability testing, etc.), and a deeper understanding of the regulatory framework of projects to plan, execute, report, and integrate testing requirements.
• Resolve moderate technical issues and conduct simple research if needed.
• Review moderate product design changes for compliance and develop/execute regressing test plans as necessary.
• Compile data and define changes required in test equipment, procedures, or new tests.
• Prepare detailed test reports and support formal verification and validation of the system.
• Interface with software/firmware developers and hardware, mechanical, and systems engineers to support verification and validation.
• Complete professional-level engineering assignments related to product safety, EMC, packaging, system testing, reliability testing, etc.
• Participate in the development, integration, verification, or validation of test methods.
• Perform safety, EMC, packaging, system testing, reliability testing, etc. assessments
• Provide an interpretation of results to applicable standards to R&D engineers and managers.
• Travel for training or as necessary to aid in program facilitation (10%).

Required Qualifications

• Bachelor’s degree in a relevant field with more than seven years relevant experience, Master’s degree in a relevant field with more than six years relevant experience, or Ph.D. with more than three years relevant experience
• Licensing or certification as applicable
• Ability to be onsite, Monday – Friday, at Biotex headquarters in Houston, TX
• Ability to be a self-starter with the highest level of integrity in the successful completion of tasks or projects
• Advanced organizational skills and attention to detail
• Excellent oral and written communication and documentation skills
• Pro-active problem-solving skills
• Ability to work cooperatively and effectively with others to establish and maintain good working relationships
• Ability to collaborate with multi-disciplinary groups and functions on site
• Familiarity with general laboratory test equipment and methods
• Ability to adapt and work in an FDA-regulated environment
• Knowledge of regulations and standards affecting the medical device industry