Technical Program Manager, Regulated Software & Firmware

Neogen Corporation • Oakdale, MN

5d • 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 software and firmware delivery plans, partnering with internal engineering teams and external development partners to ensure releases are planned, developed, verified, documented, and delivered in accordance with product and regulatory requirements.

This technically grounded program leadership role coordinates software, firmware, and hardware dependencies throughout the product lifecycle. Responsibilities span new product development, portfolio modernization, and sustaining engineering, as well as requirements traceability, design controls, verification and validation, release readiness, and external partner coordination. The position is based in Oakdale, Minnesota and requires regular collaboration with cross-functional engineering and business teams.

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 with interdependent software, firmware, and hardware 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.
• Strong technical understanding of software and firmware product development and ability to understand technical architecture, dependencies, implementation risks, and integration challenges without serving as the primary software architect.
• Strong program-planning and execution skills, including translating high-level product and business objectives into actionable engineering delivery plans.
• Ability to manage multiple workstreams, stakeholders, technical dependencies, and competing priorities.
• Strong understanding of regulated product-development practices and documentation requirements.
• Ability to drive accountability while maintaining effective relationships with technical teams and external partners.
• Strong analytical and problem-solving skills; ability to communicate technical and program information clearly to engineering teams and senior stakeholders.
• Strong attention to detail, particularly around requirements, traceability, release readiness, and regulated documentation.
• Ability to operate effectively within a cross-functional and 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 activities.
• Translate product and technical requirements and program plans into delivery plans, backlogs, milestones, and release schedules aligned with integrated product-development schedules and phase-gate requirements.
• Coordinate day-to-day execution across internal engineering teams and external development partners; track milestones, dependencies, deliverables, risks, decisions, and issues; identify risks and drive escalation and resolution.
• Maintain visibility into program status, dependencies, schedule impacts, and release readiness, and support prioritization and sequencing 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 and coordinate software and firmware activities around hardware builds, prototypes, integration windows, verification, and manufacturing schedules.
• Work with software and firmware architects and technical leads to understand implementation approaches, dependencies, risks, and constraints; support resolution of issues spanning software, firmware, hardware, platform, or system boundaries.
• Coordinate feature delivery for bundled data-management applications, including capabilities such as reporting, data export, system integration, user management, and audit trails; manage releases that may occur independently from device firmware releases.
• Coordinate requirements, development, verification, documentation, and release activities, including integration 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 following established baselines.
• Partner with Systems Engineering, Quality, Regulatory, and Engineering to complete development documentation; support verification and validation planning and execution, risk management, phase-gate evidence, certifications, and applicable design-control processes.
• Own coordination of software and firmware release readiness, including version combinations intended to ship together and completion of applicable verification, validation, documentation, and release activities.
• Coordinate release timing and readiness with Service, Manufacturing, Quality, Regulatory, Support, Platform Engineering, and other affected teams; communicate upcoming releases, changes, risks, and customer impacts.
• Support release planning for new product launches and sustaining updates; coordinate resolution of release blockers and escalate issues as appropriate.
• Coordinate external software and firmware development partners, including onshore and offshore teams; establish plans, milestones, deliverables, responsibilities, and expectations; monitor partner performance, status, dependencies, and risks.
• Facilitate communication between external partners and internal stakeholders and ensure partner-developed software and firmware align with Neogen’s technical, quality, regulatory, and documentation requirements.
• Facilitate cross-functional planning, technical coordination, issue resolution, and decision-making; communicate program status, dependencies, schedule 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