Technical Program Manager, Regulated Software & Firmware

Neogen Corporation • Oakdale, CA

6d • Onsite

About The Position

The Technical Program Manager, Software & Firmware drives delivery of software and firmware across Neogen’s regulated instrumentation portfolio. The role supports device firmware, embedded application software, and bundled data-management software that works alongside Neogen instruments. It translates product requirements and integrated program plans into executable delivery plans, partnering with internal engineering teams and external development partners, as well as Systems, Electrical, Mechanical, Quality, Regulatory, Manufacturing, Service, and Platform Engineering teams. The position ensures releases are planned, developed, verified, documented, and delivered in accordance with product and regulatory requirements, while proactively managing technical dependencies and risks throughout the product lifecycle.

This position is based in Oakdale, Minnesota and requires regular collaboration across Software, Firmware, Systems, Electrical, Mechanical, Quality, Regulatory, Manufacturing, Service, Product, and Platform Engineering teams. Neogen is a global company focused on protecting the world’s food supply through food-safety, animal-safety, and related products and solutions.

Requirements

• 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 and a gated or controlled product-development lifecycle.
• Experience with requirements management, baselining, traceability, verification and validation, change control, and risk management.
• 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.
• Strong technical understanding of software and firmware product development, including architecture, dependencies, implementation risks, and integration challenges.
• Ability to translate product and business objectives into actionable engineering delivery plans and manage multiple workstreams, stakeholders, dependencies, and competing priorities.
• Strong understanding of regulated product-development practices and documentation requirements; ability to drive accountability and communicate effectively with technical teams, external partners, and senior stakeholders.
• Strong analytical and problem-solving skills, proactive risk communication, attention to detail, and effectiveness in a cross-functional, matrixed engineering organization.

Nice To Haves

• 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 frameworks such as AOAC Performance Tested Methods, AOAC Official Methods of Analysis, AFNOR NF VALIDATION, MicroVal, ISO 16140, USDA FSIS, USDA FGIS, FDA, or Health Canada requirements.
• Experience with Azure DevOps or comparable tools for backlog management, requirements traceability, and delivery tracking.
• Experience in food safety, diagnostics, scientific instrumentation, laboratory equipment, medical devices, or life sciences.
• PMP, PgMP, Agile, Scrum, or related professional certification.
• Experience supporting sustaining engineering and product lifecycle management in addition to new product development.

Responsibilities

• Own software and firmware delivery plans across new product development, portfolio modernization, and sustaining engineering.
• Translate product and technical requirements and program plans into delivery plans, backlogs, milestones, and release schedules aligned with integrated product-development schedules and phase gates.
• Coordinate day-to-day execution across internal engineering teams and external development partners; track milestones, dependencies, deliverables, risks, decisions, and issues; and escalate and resolve delivery risks.
• Maintain visibility into program status, dependencies, schedule impacts, release readiness, and prioritization across products and initiatives.
• Coordinate delivery across device firmware, embedded application software, bundled data-management software, and related technical components.
• Partner with Systems, Electrical, and Mechanical Engineering to manage cross-disciplinary dependencies, hardware builds, prototype availability, integration windows, verification activities, and manufacturing schedules.
• Work with software and firmware architects and technical leads to understand implementation approaches, dependencies, risks, and constraints, and help resolve issues spanning software, firmware, hardware, platform, or system boundaries.
• Coordinate feature delivery for bundled data-management applications, including reporting, data export, system integration, user management, and audit trails; manage releases that may be independent of device firmware releases.
• Coordinate requirements, development, verification, documentation, and release activities across product teams, including integrations with connected applications, LIMS, cloud platforms, enterprise systems, or other external systems as applicable.
• Support requirements baselining and traceability from requirements through implementation, testing, and verification evidence; coordinate requirements changes and change control.
• Partner with Systems Engineering, Quality, Regulatory, and Engineering to complete development documentation, verification and validation planning and execution, phase-gate and certification evidence, and software and firmware risk management in alignment with design controls.
• Own coordination of release readiness and clarify which software, firmware, and product versions are intended to ship together.
• Confirm verification, validation, documentation, and release activities are complete; coordinate release timing and readiness with affected teams; communicate upcoming releases, changes, risks, and customer impacts; and coordinate or escalate release blockers.
• Coordinate external software and firmware development partners, establish plans and expectations, monitor performance and delivery risks, facilitate communication, and ensure partner deliverables meet Neogen’s technical, quality, regulatory, and documentation requirements.
• Facilitate cross-functional program planning, technical coordination, issue resolution, and decision-making; communicate status, dependencies, risks, decisions, and recommendations to engineering teams and leadership.
• Support continuous improvement of software and firmware delivery practices, planning processes, and cross-functional coordination.
• Perform other duties as assigned.

Benefits

• Medical, dental, and vision coverage beginning on the first day of employment.
• 401(k) with company match.
• Generous paid time off.
• Career growth opportunities, including tools, training, and support for career development.
• Meaningful work with impact on customers, communities, and the world.
• Collaborative culture valuing innovation, respect, teamwork, and continuous improvement.
• Competitive benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level