Jobs at JenaValve Technology

Lead operational quality functions for transcatheter heart valves and delivery systems, ensuring regulatory-compliant manufacturing, supplier quality, sterilization, microbiological control, process validation, and continuous improvement while building high-performing quality teams and enabling manufacturing transfers and scale-up.

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.

Lead regional commercial strategy and execution for TAVR/structural heart, drive revenue and case volume, develop accounts and clinical adoption, recruit and coach sales and clinical teams, support clinical cases, maintain CRM/forecasting, ensure compliance, and travel extensively to support hospital accounts.

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 revenue, account development, and clinical engagement for structural heart devices. Collaborates with clinical support specialists, conducts on-site technical discussions, delivers workshops, supports pre-case planning and device deployment, gathers clinical feedback for R&D, and executes business plans across assigned PNW territory (20-30% travel).

Field-based territory sales manager responsible for driving revenue, account development, and clinician engagement for structural heart devices. Provides clinical and technical support, coordinates cross-functional resources, conducts presentations and workshops, gathers field feedback for R&D, and achieves sales goals within the assigned NY/NJ territory. Travel 20-30%.

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%.

Design, develop, test, and document components and subsystems for transcatheter heart valves and delivery systems. Support procurement, assembly procedures, design verification, risk analysis, and transfer to manufacturing. Supervise technicians and collaborate with Quality and Manufacturing.

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.

Lead and manage the clinical compliance program for active clinical studies including risk-based audit programs, vendor qualification and oversight, CAPA management, SOP lifecycle and document control, regulatory intelligence (GCP/FDA/ICH/ISO), internal training, and direct supervision of a Clinical Compliance Specialist. Partner closely with Quality to ensure alignment and inspection readiness.

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 advance product safety risk management across the medical device portfolio, ensuring ISO 14971‑aligned practices from concept through post‑market. Develop policies, tools, and governance; support cross‑functional risk decisions; oversee risk management files, post‑market safety activities, regulatory submissions, audits, and metrics to ensure inspection readiness and patient safety.

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.

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.

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.

Lead supply chain planning and S&OP for an assigned portfolio, align demand and supply across functions and sites, manage inventory and ERP data, analyze forecast accuracy and KPIs, and execute risk mitigation to support production and business objectives.

Lead case planning and execution for global clinical trials, coordinate CRB meetings, manage imaging and screening workflows, develop SOPs and charters, mentor junior staff, and liaise with sites, core labs, and cross-functional teams to ensure timely subject enrollment and trial readiness.

Support clinical compliance operations including audit logistics, TMF/eTMF management, CAPA and non-conformance tracking, vendor qualification, SOP and training administration, and compliance metrics reporting to ensure inspection readiness and alignment with Quality.

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%.