Technical Program Manager – Hardware/Software Integration, Medical Devices | On-site role.

Xlysi LLC.; Hanover (NH); On-site; USD 120,000 - 160,000; Full time

Job summary

Xlysi LLC in Hanover, NH seeks an experienced Technical Program Manager to lead the development and integration of a wearable medical device platform, combining embedded hardware with a cloud-native software platform. You will own the program schedule end-to-end, aligning hardware milestones with software delivery to meet regulatory and safety requirements.

You will coordinate across mechanical, electrical, firmware, software, and clinical/regulatory teams, manage long-lead procurement and risk,

Qualifications

• Bachelor's degree in Mechanical, Electrical, Electronics, Computer Engineering or closely related field.
• 5+ years of Technical Program Management or Systems Integration experience on hardware/software programs.
• Experience managing hardware development lifecycles and schedules that constrain downstream software timelines.
• Strong knowledge of embedded systems, hardware-software interfaces, and cloud/software architecture.
• Experience leading Agile software delivery with hardware teams.
• Excellent stakeholder management, communication and presentation skills across hardware/software domains.
• Ability to manage multiple priorities in a fast-paced, cross-functional environment.

Responsibilities

• Own the integrated hardware/software program schedule, sequencing software milestones to hardware readiness.
• Coordinate across mechanical, electrical, firmware, software and cloud engineering teams.
• Track hardware long-lead procurement and flag schedule risks to software/integration workstreams.
• Manage hardware-software interfaces including sensors, APIs and firmware-to-cloud data pipelines.
• Lead end-to-end software platform delivery (cloud backend, data pipeline, clinician dashboard).
• Coordinate hardware bring-up, bench validation and safety/compliance testing.
• Escalate cross-partner blockers early given hardware schedule sensitivity.
• Facilitate technical reviews, milestones, and executive status reporting.
• Support healthcare interoperability initiatives (HL7/FHIR) for the software layer.
• Ensure security-by-design, safety and regulatory compliance practices (FDA readiness).
• Manage vendor and stakeholder relationships across hardware suppliers and software partners.

Skills

H/W-S/W Co-Dev

Schedule Management

Embedded Systems

APIs & Integration

Agile/Scrum

Stakeholder Mgmt

Risk Management

Healthcare Tech

Cross-Functional Leadership

Medical Devices

Hardware/Software Integration

Education

Bachelor's degree in Engineering

Job description

Technical Program Manager – Hardware/Software Integration, Medical Devices| On-site role.

• Hanover, NH

Core Competencies

• Hardware/Software Co-Development Program Management
• Hardware Schedule & Critical Path Management
• Embedded Systems & Sensor Integration
• Supply Chain & Long-Lead Procurement Awareness
• API & Systems Integration
• Agile/Scrum Software Delivery
• Stakeholder Management Across Hardware & Software Partners
• Risk & Dependency Management
• Healthcare/Medical Device Technology
• Cross-Functional Leadership
• Industry:Medical Devices / Healthcare Technology / Hardware-Software Integration

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.