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Technical Program Manager - Hardware/Software Integration, Medical Devices
Technical Program Manager Hardware/Software Integration, Medical Devices
Location: Hanover, NH
Position Summary: Seeking an experienced Technical Program Manager to lead the development and integration of a wearable medical device platform combining embedded hardware (sensors, PCBs, mechanical/electrical subsystems) with a cloud-native software platform. This role owns the program schedule end-to-end across hardware and software workstreams, with particular emphasis on sequencing software delivery against hardware development milestones since hardware lead times (PCB fabrication, component procurement, mechanical tooling, bring-up, and safety verification) typically drive the critical path and dictate the overall program timeline.
Key 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.
Required Qualifications:
- 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.
Preferred Qualifications:
- 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.
Nice to have Qualification:
- 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.
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