Jobs at JenaValve Technology

Support full-cycle HR including recruiting, onboarding, benefits administration, HRIS recordkeeping (PayCom), job description management, internship/referral programs, compliance with employment laws, and ad-hoc HR projects.

Use FEA (Abaqus) and test method development to design, validate, and document components and subsystems for transcatheter heart valves and delivery systems. Develop assembly and manufacturing procedures, partner with Quality and Manufacturing on risk analysis and verification, procure components, and transfer designs to external manufacturers following medical device quality system requirements.

Provide hands-on manufacturing engineering support for THV production: troubleshoot equipment, optimize processes using lean principles, create work instructions and training, perform data analysis and CAPA/root cause investigations, lead process improvements, support equipment/fixture design, and execute process characterization and validation to ensure quality and regulatory compliance.

Lead cross-functional teams to plan, execute, and launch heart valves, delivery catheters, and related components. Manage schedules, budgets, risks, regulatory compliance (FDA/ISO), quality systems, stakeholder communications, and technical requirements throughout product development and commercialization.

Design and develop components and subsystems for transcatheter heart valves and delivery systems. Create and review drawings/specifications, develop test methods, conduct analyses and verification testing, partner with Quality and Manufacturing, perform vendor evaluation and failure analysis, and supervise R&D technicians.

Lead regional commercial strategy and growth for TAVR/structural heart products. Drive revenue, case volume, and account adoption; recruit and develop sales and clinical teams; support clinical cases; collaborate cross-functionally; maintain CRM, forecasting and compliance; travel extensively to manage hospital relationships and field operations.

Field-based territory sales manager responsible for driving sales and revenue for Jenavalve devices within an assigned Midwest territory. Builds account plans, engages physicians and hospital staff with clinical and technical product education, coordinates with Territory Support and Regional Therapy Specialists, supports pre-case planning and device deployment, gathers field feedback for R&D, and maintains relationships with implanting centers and supply chain stakeholders. Travel ~20-30%.

Support clinical trial safety by assessing and reporting adverse events, performing MedDRA coding support, preparing narratives and safety reports, monitoring AE/SAE timeliness, collaborating with cross-functional teams, and contributing to protocol safety sections and DSMB/CEC activities.

Lead a team of Site Managers while overseeing site management across clinical trials to ensure GCP and regulatory compliance, data integrity, TMF inspection readiness, CRO/vendor performance, site activation and enrollment, and cross-functional coordination. Split role between people management and hands-on study/site oversight; travel up to 25%.

Provide quality engineering support for transcatheter heart valve manufacturing including process characterization/validation (IQ/OQ/PQ), inspection and DHR review, test protocol/report creation, nonconformance investigations, root cause analysis, CAPA implementation, audit support, and cross-functional process improvements.

Support conduct of pre- and post-market clinical studies: manage site interactions, data review and queries, maintain trial master files and regulatory documents, assist audits and monitoring, and support vendor management and process improvements.

Lead second-shift THV production teams across tissue processing, valve assembly, solutions mixing, and tool cleaning. Manage planning, staffing, training, quality, KPIs, inventory, GMP compliance, troubleshooting, continuous improvement, and cross-functional coordination to support new product commercialization.

Lead and build an in-house clinical data management function: manage a team, own end-to-end data cleaning and query processes, partner with Clinical Operations, CROs, and Biostatistics, ensure CDISC-compliant datasets, support audits and regulatory submissions, and oversee EDC systems and SOPs.

Support site management and data activities for pre-market clinical studies, ensure GCP and regulatory compliance, maintain TMFs, provide EDC training, generate queries and reports, assist monitors, support audits and vendor management, and contribute to process improvements.

Support conduct of pre- and post-market clinical studies by managing site interactions, data review and query resolution, maintaining trial master files, managing regulatory documents, supporting audits/inspections, and assisting monitoring and vendor qualification activities to ensure GCP and regulatory compliance.