Jobs at Caldera Medical

Coordinate interview logistics, candidate communication, and recruitment administration. Maintain ATS records, schedule interviews across departments, support candidate travel and onboarding, manage agency relationships, track basic recruiting metrics, and ensure compliance with EEO and company policies.

Maintain regulatory systems, trackers, and submission pipelines for medical device registrations. Compile and publish submission packages, submit via agency portals, update registries (EUDAMED, GUDID, Swissmedic), perform data audits, manage correspondence and archives, enforce SOPs, and support cross-functional RA/QA workflows.

Own in-house design of the Gynesis therapeutic garment: construction, electrode integration, fit/sizing and durability. Drive material and manufacturability decisions, run benchtop and prototype tests, manage contract-manufacturer NRE and design transfer, capture DFMEA/DHF risk documentation, and protect construction IP for regulatory submission and commercialization.

Lead end-to-end go-to-market for the Gynesis neuromodulation platform, build a three-pillar commercial engine (DTC, physician/channel, business development), create brand and education-led pre-clearance messaging, establish KOL and physician partnerships, own pricing and reimbursement narrative, stand up DTC infrastructure and metrics, hire and lead the GTM team, and align commercial plans with regulatory and product timelines toward a Jan 1, 2027 go-live.

Own the end-to-end product definition and roadmap for the Gynesis neuromodulation platform. Translate clinical, reimbursement, and market needs into prioritized requirements, maintain the backlog, align engineering/regulatory/commercial teams, support 510(k) submissions, and guide future product and go-to-market strategy including BLE/app/provider-portal development.

Own and develop the Gynesis device firmware and accessory-app backend, produce submission-grade documentation (SBOM, cybersecurity artifacts) for FDA 510(k), establish source control and build processes, and help architect a BLE wireless roadmap while collaborating with hardware, regulatory, and quality teams.

Lead in-house hardware and systems engineering for a neuromodulation controller: author/maintain requirements, plan and execute V&V, manage design transfer to CM, coordinate electrical interfaces, drive EMC/electrical-safety testing, and maintain DHF and risk documentation toward FDA 510(k) submission.

Develop and implement global medical device regulatory strategies, prepare and submit regulatory dossiers, interface with agencies and Notified Bodies, support post-market surveillance and audits, guide cross-functional teams and junior staff, and maintain compliance with international regulations throughout product lifecycle.

Lead upstream and downstream marketing for the US Implant business unit: define positioning, own go-to-market strategy and product launches, build sales enablement, run demand generation and KOL engagement, capture customer insight, track marketing KPIs/ROI, manage budget/vendors, and mentor or manage marketing staff. Requires ~30% travel.

Own national accounts strategy and execution to secure GPO/RPO/IDN contracts across Implant and Surgical business units. Develop market assessments, pricing and negotiation strategies, lead penetration efforts with sales leadership, monitor KPIs, manage contracting, legal and compliance, and build relationships with field sales to drive share and access.

Lead and grow a West-region medical device sales team to exceed quotas, recruit and develop top talent, build KOL and IDN/GPO relationships, and drive OR/hospital sales. Role requires heavy travel and hands-on coaching to meet monthly, quarterly and annual targets.