Employees at HLT are passionate about their work to create a new transcatheter aortic valve replacement (TAVR) technology that improves people’s lives.
People at every level have opportunities to work on project teams, think creatively and grow professionally. We offer a fast paced, friendly environment where employees work hard and have fun at the same time.
Now is an exciting time to join HLT as we prepare to start human clinical trials.
Check out our job openings and if you don’t see a position that fits your background, we still want to hear from you. Submit your resume and cover letter to our Human Resources department at firstname.lastname@example.org.
Senior R&D Scientist/Engineer
This position will support the R&D team and cross functional team by conducting activities critical to valve development and testing. The primary responsibility will be developing the tissue component of the valve. This position is responsible for understanding and improving all aspects of preparing tissue for assembly into a valve, from sourcing raw material to final selection and quality control criteria. In addition, this position is responsible for ensuring overall sterility and biocompatibility of valve and delivery system designs. This includes managing initial biocompatibility testing and sterilization validations for new products as well as helping to create plans for ongoing assurance of sterility and biocompatibility for clinical product.
Sr. Delivery System Specialist
The primary function of this position is to support the Delivery System manufacturing operations and development. The Sr. Delivery System Specialist will perform activities associated with the manufacturing of medical devices such as hand assembly, molding and forming operations, cleaning, and inspection. In addition, the Sr. Delivery System Specialist will be responsible for maintaining processes and procedures, equipment, and assisting in validation and verification activities. The Sr. Delivery System Specialist will possess the ability to adjust and adapt from development to manufacturing while maintaining the integrity of the Delivery System manufacturing area and the organization.
Manager, Tissue and Sterilization
Manage and lead Tissue Processing and Sterilization group. This position is responsible for understanding and improving all aspects of preparing tissue for assembly into a valve, from sourcing raw material to final selection and quality control criteria. In addition, this position is responsible for ensuring overall sterility of valve and delivery system products. This includes creating plans for routine monitoring of sterility for clinical devices. Responsible for documenting, implementing, and improving the Tissue and Sterilization processes. Manage and lead process development and process verification/ validation activities. Manage cross functional projects; assure activities are completed within prescribed schedules and efficiently utilize resources. Provide required and necessary training to production operators and other manufacturing personnel.
Senior Regulatory Affairs Specialist
The HLT Senior Regulatory Affairs Specialist will engage in planning and execution of global regulatory activities necessary to support implementation of clinical trials and subsequent commercial distribution of HLT transcatheter aortic valve systems. This position will provide regulatory functional representation and review of documentation related to clinical trials, labeling, design and specification, and manufacturing processes, as applicable to area of responsibility and according to US and international regulations, standards, and guidance.
Manage and lead Tissue Valve Assembly manufacturing group. Responsible for documenting, implementing, and improving the manufacturing processes, specifically Valve Assembly manufacturing. Manage and lead process development and process verification/validation activities. Manage cross functional projects; assure activities are completed within prescribed schedules and efficiently utilize resources. Identify, construct and implement improvements to process or design. Provide required and necessary training to production operators and other manufacturing personnel.
Sr. Quality Engineer
Provide product quality, design assurance and expertise to product development projects. Provide risk management throughout entire product lifecycle and assure compliance to HLT design control system. Lead cross functional projects; assure activities are completed within prescribed schedules and efficiently utilize resources. Identify areas of improvement, and either lead the necessary activities to completion or participate as an active member providing guidance to the team.
Provide hands-on technical quality engineering support for new product transitions internally and externally into production including development of quality requirements/plans for new products, design/process validation requirements, test method validation and ongoing change management for finished device manufacturing.