Technical Program Manager, Regulated Software & Firmware

It's fun to work in a company where people truly believe in what they are doing!
The Technical Program Manager, Software & Firmware is responsible for driving the delivery of software and firmware across Neogen’s regulated instrumentation portfolio. This role supports device firmware, embedded application software, and bundled data-management software that works alongside Neogen instruments.
This is a technically grounded program leadership role that translates product requirements and integrated program plans into executable software and firmware delivery plans. The Technical Program Manager partners closely with internal engineering teams, external development partners, Systems Engineering, Electrical Engineering, Mechanical Engineering, Quality, Regulatory, Manufacturing, Service, and Platform Engineering to ensure releases are planned, developed, verified, documented, and delivered in accordance with product and regulatory requirements.
The successful candidate will bring both technical depth and strong program execution skills, with the ability to understand software, firmware, and hardware dependencies and proactively manage risks throughout the product lifecycle.
Essential Duties and ResponsibilitiesTechnical Program and Delivery Management
Own software and firmware delivery plans across new product development, portfolio modernization, and sustaining engineering activities.
Translate product requirements, technical requirements, and program plans into executable delivery plans, backlogs, milestones, and release schedules.
Align software and firmware delivery plans with integrated product-development schedules and phase-gate requirements.
Coordinate day-to-day program execution across internal engineering teams and external development partners.
Track milestones, dependencies, deliverables, risks, decisions, and issues throughout the development lifecycle.
Identify delivery risks early and drive appropriate escalation and resolution.
Maintain clear visibility into program status, dependencies, schedule impacts, and release readiness.
Support prioritization and sequencing of development activities across multiple products and initiatives.
Software, Firmware, and Hardware Integration
Coordinate delivery across device firmware, embedded application software, bundled data-management software, and related technical components.
Partner with Systems, Electrical, and Mechanical Engineering to identify and manage cross-disciplinary dependencies.
Coordinate software and firmware activities around hardware builds, prototype availability, integration windows, verification activities, and manufacturing schedules.
Work closely with software and firmware architects and technical leads to understand implementation approaches, technical dependencies, risks, and development constraints.
Support resolution of issues that span software, firmware, hardware, platform, or system boundaries.
Ensure technical dependencies are reflected appropriately within program and release plans.
Software Product and Feature Delivery
Coordinate ongoing feature delivery for bundled data-management applications supporting Neogen instrumentation.
Support delivery of capabilities including reporting, data export, system integration, user management, audit trails, and related product functionality.
Manage software releases that may occur independently from device firmware releases.
Coordinate requirements, development, verification, documentation, and release activities across product teams.
Support integration with connected applications, LIMS, cloud platforms, enterprise systems, or other external systems as applicable.
Requirements, Traceability, and Design Controls
Support requirements baselining and ensure appropriate traceability from requirements through implementation, testing, and verification evidence.
Coordinate requirements changes and change-control activities following established product baselines.
Partner with Systems Engineering, Quality, Regulatory, and Engineering teams to ensure required development documentation is completed.
Support verification and validation planning and execution for software and firmware deliverables.
Ensure evidence required for development phase gates, certifications, and regulated product-development activities is available and complete.
Support risk-management activities related to software and firmware development and release.
Maintain alignment between program execution and applicable design-control processes.
Release Management and Readiness
Own coordination of software and firmware release readiness across assigned products.
Establish clarity around which software, firmware, and product versions are intended to ship together.
Confirm applicable verification, validation, documentation, and release activities have been completed before product release.
Coordinate release timing and readiness with Service, Manufacturing, Quality, Regulatory, Support, Platform Engineering, and other affected teams.
Ensure downstream stakeholders have appropriate visibility into upcoming releases, changes, risks, and customer impacts.
Support release planning for both new product launches and sustaining product updates.
Coordinate resolution of release blockers and escalate issues when appropriate.
External Development Partner Management
Coordinate execution with external software and firmware development partners, including onshore and offshore teams.
Establish clear plans, milestones, deliverables, responsibilities, and expectations for external partners.
Monitor partner performance, delivery status, dependencies, and risks.
Facilitate communication between external partners and internal technical and business stakeholders.
Ensure externally developed software and firmware aligns with Neogen technical, quality, regulatory, and documentation requirements.
Cross-Functional Collaboration
Partner closely with Software, Firmware, Systems, Electrical, Mechanical, Product Management, Quality, Regulatory, Manufacturing, Service, and Platform Engineering teams.
Facilitate program planning, technical coordination, issue resolution, and decision-making across functions.
Communicate program status, technical dependencies, schedule risks, decisions, and recommendations clearly to engineering teams and leadership.
Provide proactive communication when risks, delays, or technical issues may affect delivery.
Support continuous improvement of software and firmware delivery practices, planning processes, and cross-functional coordination.
Perform other duties as assigned.
Basic Qualifications
Bachelor’s degree in Engineering, Computer Science, Software Engineering, or a related technical discipline, or equivalent practical experience.
Professional engineering experience working with embedded software, firmware, application software, instrumentation, or other hardware-connected products.
Two or more years of experience in technical program management, project management, delivery management, or technical leadership coordinating delivery across engineering teams.
Technical understanding of how software, firmware, and hardware are developed, integrated, tested, and released.
Experience delivering products where software, firmware, and hardware have interdependent development schedules.
Experience working within a regulated product-development environment.
Experience with requirements management, baselining, traceability, verification and validation, change control, and risk management.
Experience working within a gated or controlled product-development lifecycle.
Understanding of data-integrity principles applicable to regulated software, including audit trails, electronic records, electronic signatures, and access controls.
Familiarity with regulatory, certification, or method-validation frameworks applicable to regulated instrumentation or comparable regulated products.
Experience coordinating technical work across multiple engineering disciplines.
Demonstrated ability to identify program risks, dependencies, and delivery issues and escalate them appropriately.
Strong technical communication, problem-solving, organization, and stakeholder-management skills.
Preferred Qualifications
Experience coordinating external software or firmware development partners, including offshore or distributed teams.
Experience with embedded Linux, Yocto, or similar embedded platforms.
Experience with Qt-based applications.
Experience delivering desktop, embedded, or connected applications that manage instrument data.
Experience with LIMS, cloud-platform, or enterprise-system integrations.
Experience supporting software developed in accordance with ISO 62304 or comparable regulated software-development standards.
Familiarity with 21 CFR Part 11 requirements.
Familiarity with food-safety validation and regulatory framework