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Neogen

Develops and markets food safety tests

Technical Program Manager - Regulated Software & Firmware

Program ManagementUpdated on Nov 10
Full-timeOakdale, MN, USANo salary listed

About the Job

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.
  • 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.
  • Ability to understand technical architecture, dependencies, implementation risks, and integration challenges without serving as the primary software architect.
  • Strong program-planning and execution skills.
  • Ability to translate 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 both engineering teams and senior stakeholders.
  • Ability to identify issues early and communicate risks proactively.
  • 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.
  • Employment is contingent upon successful completion of applicable pre-employment requirements and verification of identity and authorization to work in the United States.

Responsibilities

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Desired 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 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.

About the Company

Neogen

Develops and markets food safety tests

Neogen develops and markets test kits and services to detect a range of safety issues in the food and animal supply chain. Its products help identify foodborne bacteria, natural toxins, and drug residues in animals, and the company divides its offerings into two segments: Food Safety and Animal Safety. Products are delivered as test kits and related services that enable customers to screen and verify safety at various stages from farm to fork. The firm differentiates itself through its scale and geographic reach, a consequence of the 2022 merger with 3M’s food safety business that nearly doubled its size and created a global leader in food safety by expanding product lines and geographic footprint. Neogen’s goal is to ensure the safety of the world’s food supply by providing comprehensive tools and services that detect contaminants and residues across the food and animal industries.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Lansing, MI
Founded
1982

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