Head of Technical Operations and Clinical Engineering
$140k - $180k/yr
Expert
Bachelor's
Chicago, IL, USA
Remote
Biology & BiotechBiomedical Engineering & Medical Devices
About the job
Requirements
- Bachelor's degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Computer Engineering, or a related technical field.
- 8+ years of experience in medical devices, digital health, clinical engineering, healthcare technology, or a related technical environment.
- Demonstrated experience leading technical deployments, implementations, or integrations within hospitals or health systems.
- Experience working directly with hospital stakeholders, including clinicians, clinical engineering or biomed, information technology, information security, and research teams.
- Strong analytical skills with experience developing metrics, dashboards, reporting, or other data-driven tools used to monitor performance and support business decisions.
- Working knowledge across hardware, software, and clinical workflows, with the ability to communicate effectively with specialized teams in each area.
- Experience developing and implementing new operational processes, particularly in environments where processes and infrastructure are still being built.
- Demonstrated ability to independently scope problems, identify solutions, make decisions, and drive workstreams through completion.
- Strong cross-functional leadership and communication skills, with the ability to translate technical information for clinical, commercial, and operational audiences.
- Experience managing multiple concurrent workstreams with competing priorities in a fast-paced environment.
Responsibilities
- Own end-to-end deployment for new customers, from technical scoping through go-live and steady-state support.
- Serve as the primary point of contact to hospital information technology, biomedical or clinical engineering, and information security teams.
- Define and maintain onboarding procedures, including device procurement and provisioning, fleet management, workflow mapping, and staff training.
- Manage integration workstreams with hospital systems and third-party cardiac data platforms, coordinating with engineering on interfacing requirements and data flow.
- Build the field support model, including tiering, service-level agreements, and feedback to research and development.
- Support Commercial in defining successful deployment, including activation milestones, sustained utilization thresholds, and per-site economics.
- Own instrumentation and reporting of device and platform usage, building the metrics infrastructure and recurring reporting cadence used by Commercial for account decisions.
- Own account monitoring across deployed sites, including utilization, workflow breakdowns, and technical friction, to enable early intervention.
- Translate deployment and utilization data into commercial strategy inputs and contribute to commercial planning.
- Own technical and operational content for customer-facing materials that support solution expansion and increase site utilization.
- Manage contract manufacturing and external design partners, including statements of work, build plans, cost, yield, and quality.
- Drive the accessory and device improvement roadmap through partners from requirements through design transfer and verification.
- Own build planning and inventory across the demo program, clinical studies, and commercial deployment.
- Support execution of clinical validation studies demonstrating the performance and clinical utility of Cardiosense solutions, with commercialization endpoints defined early.
- Provide operational and technical support to clinical studies, including site activation, device logistics, and data integrity.
- Provide oversight on data monitoring and execution, flagging when sites drift out of protocol early.
- Provide real-world usage insights to prioritized requirements for the algorithm and applications team.
- Identify data collection opportunities that support algorithm improvements and expansion indications in coordination with the PCCP framework.
- Advise on product roadmap tradeoffs where deployment feasibility, manufacturability, or clinical utilization are gating factors.
About the company
Cardiosense develops a non-invasive cardiac monitoring platform that uses wearable biometric sensors and artificial intelligence to analyze the full electromechanical behavior of each heartbeat. The system continuously tracks heart electrical signals and mechanical activity to provide early warnings of declining heart function. By selling the devices and offering a subscription-based analytics platform, Cardiosense targets hospitals and clinics to help healthcare teams prioritize at-risk patients and enable proactive interventions. Unlike traditional monitoring that relies on invasive methods or single-signal data, Cardiosense combines multiple data streams and AI-driven insights to detect signs of deterioration before symptoms appear. The company aims to improve patient outcomes by enabling timely care while the technology remains investigational under U.S. law.
Company Size
11-50
Company Stage
Series A
Total Funding
$15.1M
Headquarters
Chicago, Illinois
Founded
2020
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Simplify's Take
What believers are saying
- May 27, 2026 FDA De Novo removed the biggest regulatory barrier for commercialization.
- July 2025 510(k) clearance lets Cardiosense sell CardioTag now, not after further trials.
- August 24, 2026 private placement added $26.1 million to fund sales and studies.
What critics are saying
- CMS’s SaMS framework remains proposed in July 2026, delaying reimbursement decisions.
- Authorization covers only HFrEF Class II-IV and adjunctive PCWP use, limiting addressable revenue.
- Without payer adoption, hospitals keep using catheters and implanted sensors, starving Cardiosense of sales.
What makes Cardiosense unique
- CardioTag captures ECG, PPG, and SCG simultaneously from one chest patch.
- May 27, 2026 FDA De Novo made PCWP Analysis Software first authorized noninvasive PCWP tool.
- SEISMIC-HF I validated the algorithm in 310 HFrEF patients against right-heart catheterization.
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Benefits
- Hybrid Work Options
- Relocation Assistance