Note: The job is a remote job and is open to candidates in USA. Comrise is seeking a Technical Program Manager to lead the development and integration of a wearable medical device platform combining embedded hardware with a cloud-native software platform. The role owns the end-to-end program schedule across hardware and software workstreams, coordinates cross-functional and partner teams, and manages integration, risks, compliance, and healthcare interoperability initiatives.
Responsibilities
- Own the integrated hardware/software program schedule, ensuring software delivery milestones are sequenced against hardware readiness (PCB fab, component lead times, mechanical builds, bring-up, and compliance testing) rather than planned independently
- Coordinate across mechanical, electrical, and firmware engineering teams (internal and partner/vendor) alongside software and cloud engineering teams
- Track hardware long-lead procurement (components, transducers, PCB fabrication, backup sourcing) and proactively flag schedule risk to downstream software and integration workstreams
- Manage the hardware-software interface: sensor specifications, communication protocols/APIs (e.g., BLE, USB-C), firmware-to-cloud data pipelines, and version-locking between hardware spec releases and software builds
- Lead end-to-end software platform delivery (cloud backend, real-time data pipeline, clinician dashboard) using Agile/Scrum methodologies, timed to hardware integration windows
- Coordinate hardware bring-up, bench validation, and safety/compliance verification (e.g., acoustic output, electrode SNR, mechanical fit) alongside software integration testing
- Manage project plans, risks, and dependencies across multiple hardware and software partner organizations; escalate cross-partner blockers early given the schedule sensitivity of hardware workstreams
- Facilitate technical reviews, milestone/compliance demonstrations, and executive status reporting spanning both hardware and software progress
- Support healthcare interoperability initiatives, including HL7/FHIR-based integrations, for the software layer
- Ensure hardware and software development follow security-by-design, safety, and regulatory compliance best practices (including support for FDA engagement where applicable)
- Manage vendor, partner, and stakeholder relationships across hardware suppliers, software delivery partners, and clinical/regulatory stakeholders
Skills
- • Bachelor's degree in Mechanical Engineering, Electrical Engineering, Electronics Engineering, Computer Engineering, or a closely related engineering discipline. (Computer Science/Information Systems background considered only with demonstrated hardware program management experience.)
- • 5+ years of Technical Program Management or Systems Integration experience on programs combining hardware and software development
- • Demonstrated experience managing hardware development lifecycles — component sourcing/lead times, PCB fabrication, mechanical builds, bring-up, and verification/validation — and understanding how they constrain downstream software and integration schedules
- • Strong knowledge of embedded systems, hardware-software interfaces (APIs, communication protocols), and cloud/software architecture
- • Experience leading Agile software delivery teams in coordination with hardware engineering teams
- • Excellent stakeholder management, communication, and presentation skills across both hardware and software disciplines
- • Ability to manage multiple priorities and competing schedules in a fast-paced, cross-functional, multi-partner environment
- • Experience in medical device development, wearable/embedded health tech, or SaMD/hardware-inclusive regulated products
- • Familiarity with supply chain and long-lead component procurement strategies (backup sourcing, single-supplier risk mitigation)
- • Experience supporting research, government-funded, or highly regulated hardware/software technology programs
- • Experience with hardware verification & validation, safety testing, and regulatory submission support (e.g., FDA Q-Sub/510(k) pathway)
- • Knowledge of HL7, FHIR, and healthcare interoperability standards
- • Experience with cloud technologies (AWS, Azure, or GCP) and CI/CD, DevOps, observability tooling
Benefits
- Remote (within the US)
Company Overview
Company H1B Sponsorship