BioTex offers competitive salary and benefits commensurate with experience and skill level, full health benefits, merit bonuses, and employee stock option plan. Interested candidates should email a current resume to jobs @ biotexmedical . com
Quality Assurance Manager
- Ensure accurate Certificates of Conformity (CoCs).
- Address complaints
- Conduct internal audits
- Oversight of product return process, including disposition issues
- Ownership of nonconforming material (NCR) system
- Ownership of supplier quality, including interface with Corporate Supply Chain team
- Ownership of equipment calibration and preventive maintenance
- Perform comprehensive problem-solving investigations and provide compliant documentation for NCRs and CAPAs.
- Collaborate to perform data analysis and trending of key quality data.
- Calculate and communicate group performance against approved objectives (metrics and KPIs).
- Communicate relevant open QA actions, with focus on timely completions.
- Lead “back room” team during FDA, Notified Body, customer audits, and other external regulators (to provide requested documents very timely)
- Must comply with applicable ISO and FDA regulations as stated in Quality Manual
- Must embody the company’s vision, mission and values
- Bachelor’s Degree in Engineering , Life Sciences or other technical field.
- 3 years experience in Quality Assurance in Medical Device industry (preferred) or other regulated industry
- Proficiency with use of measuring instruments and reading specifications
- Strong knowledge of Quality System requirements (FDA Quality System Regulation & ISO 13485) and Risk Management (ISO 14971)
- Strong knowledge of cGMPs and domestic regulatory requirements.
- Background in statistical techniques, and measurement tools
- Proficiency with MS Word, Excel, Power Point and statistical software
"We are seeking a Manufacturing Technician to join our team! You will be part of a team creating cutting edge medical devices.
- Manufacture to a set daily goal per product (may be more than one a day)
- Maintain your production stations daily
- Count and fill inventory in your production stations daily
- Perform routine preventative maintenance
- Respond to work order requests in a timely fashion
- Adhere to all manufacturing policies and procedures
- Participate in company functions
- Previous experience in medical/clean room is preferred
- Strong mechanical aptitude and troubleshooting skills
- Familiarity with hand tools and equipment
- High school GED or equivalent.
Biotex may need to speak with your references so have those available.
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
- 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.
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.
- 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
- 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.
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.
Engineering Student Intern
A motivated undergraduate engineering students that are interested in gaining experience in the research and development of optically based medical technologies for part-time employment (20-30hrs/wk).
Duties will include assisting other engineers in research tasks that include data collection, experimentation, testing, and literature searches. Other duties will also include some light machining, assembly, and packaging of current products. Experience with lasers, optics, and electronics is a plus. Clear communication and writing skills are imperative as well as an ability to work independently.