Jobs at Calyxo

Leads commercial health plan reimbursement strategy, payer negotiations, coverage advocacy, reimbursement operations, and Market Access Manager development. Engages payer leadership, medical directors, physicians, and providers on coverage, payment, appeals, denials, and policy issues. Partners cross-functionally with Commercial, Sales, Medical Affairs, Legal, Compliance, and Finance to support launch readiness and compliant execution. Uses payer policy and claims data to guide strategy, reporting, escalation, and continuous improvement.

Provides intraoperative clinical support for CVAC kidney stone procedures, trains surgeons and hospital staff, prepares and audits equipment, troubleshoots devices, manages inventory, and supports physician and sales training. The role collaborates with Territory Sales Managers on account management, education, clinical engagement, and outcomes. Extensive travel, including up to 90% by car and travel outside the designated territory, is required.

Designs and leads development of electrical and embedded subsystems for medical devices, including PCBAs, cable harnesses, analog and mixed-signal electronics, power systems, sensors, controls, and communications. Responsibilities include embedded control prototyping, EMI/EMC compliance, verification and validation, risk analysis, troubleshooting, design transfer, contractor oversight, and cross-functional collaboration throughout the product lifecycle.

Drive CVAC adoption and sales quota attainment across the Jacksonville territory. Build relationships with physicians, urologists, and key opinion leaders; conduct product demonstrations, account training, and clinical education; generate leads; manage forecasts and territory plans; support hospital and ASC approvals; collaborate with sales, marketing, finance, customer service, and professional education teams; and ensure compliance with FDA, GMP, Sunshine Act, and company policies.

Supports U.S. and international medical device regulatory submissions, including 510(k)s, registrations, and letters to file. Provides regulatory guidance across product development, biocompatibility, sterilization, packaging, labeling, clinical strategy, promotional claims, and post-market activities. Partners with Quality, R&D, Operations, Clinical, Marketing, and Legal; supports FDA interactions, audits, inspections, CAPAs, complaints, and global compliance monitoring.

Leads commercial activity and sales growth across the North Central region for medical device products. Recruits, develops, and manages sales professionals and clinical specialists; creates regional business strategies; builds relationships with urologists, hospitals, and ASCs; supports facility approval and patient access; monitors performance; ensures regulatory compliance; and represents the company at industry events. Travel up to 60% with overnight travel required.

Drive CVAC adoption and sales quota attainment across the Buffalo territory. Develop territory plans, forecasts, customer relationships, and physician training programs; generate leads, demonstrate products, support hospital and ASC approvals, and collaborate with sales, marketing, finance, education, and customer service teams. Ensure compliance with FDA regulations, GMP, Sunshine Act policies, and facility credentialing requirements while supporting product complaints and safety issues.

Lead the architecture and development of fluidic subsystems for kidney stone treatment devices, including irrigation, aspiration, pumps, valves, sensors, tubing, and control algorithms. Define requirements, conduct modeling, prototyping, testing, risk management, and design verification. Collaborate across engineering, clinical, quality, regulatory, suppliers, and operations to deliver compliant, scalable products. Provide technical leadership, conduct design reviews, investigate root causes, guide technology roadmaps, and mentor engineers.

Leads a team responsible for medical device complaint investigations, adverse event analysis, root-cause determination, and timely regulatory-compliant case closure. Oversees investigation procedures, lab resources, documentation, audits, complaint trending, CAPA support, and post-market surveillance. Partners cross-functionally with Quality, Manufacturing, R&D, Regulatory, Clinical, Medical Affairs, and Customer Service to assess product risks, resolve failure modes, and drive continuous improvement.

Provides intraoperative clinical support for CVAC kidney stone procedures, trains surgeons and hospital staff, prepares and troubleshoots equipment, manages inventory, and supports physician, residency, and sales training. The role requires operating room experience, sterile technique, procedural guidance, hospital collaboration, and extensive travel. Clinical Specialists also assist with account management, clinical engagement, case coverage, quality audits, and compliance with medical device policies.

Provides intraoperative clinical support for CVAC kidney stone procedures, trains surgeons and hospital staff, prepares and troubleshoots equipment, manages inventory, and supports physician and sales training. The role requires operating-room experience, sterile-procedure knowledge, procedural guidance skills, and collaboration with territory sales managers. Frequent travel, including up to 90% by car and travel outside the assigned territory, is required.

Provides intraoperative clinical support for CVAC kidney stone procedures, trains surgeons and hospital staff, prepares and audits equipment, troubleshoots devices, manages inventory, and supports physician and sales training. Partners with Territory Sales Managers on account setup, clinical engagement, case coverage, education, and outcomes. Requires operating-room experience, procedural guidance skills, extensive travel, and a valid U.S. driver’s license.

Provides intraoperative clinical support for CVAC kidney stone procedures, trains surgeons and hospital staff, prepares and audits equipment, troubleshoots devices, manages inventory, supports physician education, and partners with territory sales managers on account management and clinical outcomes. The role requires operating-room experience, procedural guidance skills, extensive travel, and a valid U.S. driver’s license.

Supports sales through VAC submission coordination, customer onboarding, account setup, quotation generation, equipment evaluations, upgrades, lead delegation, and reporting. Maintains ERP and sales metrics, handles customer communications, documents interactions, supports order entry, and coordinates cross-functional process improvements while ensuring compliance and timely follow-up.

Provides intraoperative clinical support for CVAC kidney stone procedures, trains surgeons and hospital staff, prepares and troubleshoots equipment, manages inventory, and supports physician, sales, and residency education. The role requires operating-room experience, sterile-procedure knowledge, procedural guidance skills, and collaboration with territory sales managers. Travel by car may reach 90%, including travel outside the designated territory or nationally as assigned.

Architect and own system-level behavior for complex medical device systems across the product lifecycle. Responsibilities include defining system architecture, decomposing user and clinical needs into requirements, managing interfaces and risks, leading dFMEA and verification activities, validating designs through prototyping and testing, and providing technical leadership across hardware, software, mechanical, electrical, clinical, quality, and product teams.

Develop and verify C++ software for real-time medical device applications. Responsibilities include requirements analysis, risk management, test planning, automated testing, design verification, regulatory documentation, cybersecurity assessments, and software validation. The role also involves collaborating with computer vision and electrical engineering teams, supporting audits and submissions, mentoring engineers, and establishing software development and testing best practices in a regulated environment.

Manages the Albany territory to drive adoption and sales of Calyxo’s CVAC kidney stone treatment technology. Responsibilities include meeting quotas, developing territory plans and forecasts, educating and training physicians, conducting product demonstrations, building relationships with urologists and key opinion leaders, supporting hospital approvals, coordinating clinical education, resolving product issues, and maintaining regulatory and compliance standards. Frequent travel and lead generation are required.