Technical Program Manager (Hardware/Software Integration, Medical Devices)

Comrise (Hanover NH, USA) Follow 2 hours ago

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Technical Program Manager (Hardware/Software Integration, Medical Devices)

Location: Remote (within the US)
Employment Type: 12-Month Contract
Pay Rate: $40/hour (W2)
Industry: Healthcare Technology | Software Development

About the Role:

We are 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 Qualifications:

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.

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

Interview Process:

Documentation exercise. You'll be asked to prepare a document or presentation (about 2 plus hours of work) explaining a project you need to complete.
45-minute Final Panel interview via Video. During the video interview, they'll discuss your thought process behind the documentation exercise, as well as your overall experience and qualifications for the role.

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