Jobs at JenaValve Technology

Develops and documents components and subsystems for transcatheter heart valves and delivery systems. Performs engineering analysis, feasibility testing, risk analysis, and design verification. Collaborates with Quality and Manufacturing on procedures, processes, and product transfer to external manufacturers. Procures components, develops assembly procedures, and supervises technicians while ensuring compliance with medical device quality systems.

Leads quality systems and quality engineering activities for medical device product development and commercialization. Manages CAPA, nonconformances, MRB, audits, management reviews, quality metrics, inspection readiness, eQMS enhancements, software validation, returned-goods compliance, and global KPI harmonization. Provides technical guidance, supports regulatory and supplier audits, drives process improvements, and promotes quality-system training and compliance with FDA, ISO, EU MDR, and MDSAP requirements.

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.

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.

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.

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 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.

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.