Head of Product Development and Technology

About BioGenex

BioGenex designs, develops and commercializes molecular pathology systems for tumor diagnosis, prognosis, precision medicine and life science research. Its business combines automated molecular pathology workstations with antibodies, probes, detection systems, retrieval solutions, histology stains, reagents and consumables for immunohistochemistry, in situ hybridization, fluorescence in situ hybridization, multiplex staining, microRNA and related tissue-based applications. BioGenex serves pathologists, histotechnologists, clinical and reference laboratories, biotechnology and pharmaceutical organizations, and academic researchers.

About the Role

BioGenex is looking for a Technical / Functional Head to direct product development and technical operations across molecular pathology, laboratory automation and regulated diagnostic systems. The role will align scientific R&D, engineering, software and firmware, verification and validation, manufacturing transfer and technical program management around a common product roadmap.

The position is accountable for converting business, customer and clinical needs into reliable, compliant and commercially relevant products from concept through lifecycle support. The incumbent will set technical priorities, allocate resources, manage portfolio risks, develop leaders and communicate decisions to senior leadership. This is not a coding position, but it requires the ability to guide software teams, review architecture and development plans, assess technical risks, and ensure appropriate verification, validation and release controls.

Key Responsibilities

Define and execute the product and technology strategy, roadmap and investment priorities, including decisions on external technologies, collaborations and strategic partnerships.

Translate clinical needs, pathology laboratory workflows, customer feedback and business priorities into clear product requirements and development programs.

Direct scientific product development across histology, FFPE workflows, IHC, ISH, FISH, multiplex staining, RNA and miRNA detection, and related tissue-based applications, ensuring appropriate analytical performance and scientific evidence.

Lead integrated systems development across mechanical engineering, electronics, thermal control, fluidics, motion control, embedded firmware, product software, reagents and consumables.

Lead product software and firmware through qualified managers, with oversight of architecture, development planning, cybersecurity, interfaces, testing, configuration management, release control and maintenance.

Establish technical governance covering system architecture, requirements traceability, product risk, design reviews, stage gates, escalation paths and release readiness decisions.

Own technical portfolio plans, departmental budgets, headcount, milestones, resource allocation, external partners, vendors, major risks and executive reporting.

Ensure that integrated verification and validation plans, test methods, acceptance criteria, traceability and objective evidence cover the complete product and workflow.

Lead design transfer and manufacturing readiness, including product specifications, bills of materials, drawings, software versions, calibration, supplier qualification, pilot builds and process validation.

Partner with Manufacturing and Quality to improve yield, product consistency, cost, reliability and serviceability, and to resolve significant production and field performance issues.

Partner with Quality Assurance and Regulatory Affairs on design controls, product risk management, technical documentation, regulatory submissions, product claims, CAPA and post-market activities.

Recruit, develop and retain scientific, engineering, software and program management leaders; set objectives, review performance and build succession plans.

Key Technical Areas

Molecular and tissue-based diagnostics

Embedded firmware and product software

Histology and FFPE workflows

Software lifecycle and cybersecurity

IHC, ISH and FISH

Risk management and design controls

Multiplex and spatial biology

Verification and validation

Antibodies, probes and detection chemistry

Technology transfer and scale up

Analytical and performance validation

Instrument and reagent manufacturing

Systems engineering and requirements

Reliability, serviceability and CAPA

Mechanical, electronics and fluidics

ISO 13485 quality systems

Requirements

Qualifications

Master's degree or doctorate in molecular pathology, molecular biology, biotechnology, biochemistry, biomedical engineering, medical device engineering or a related discipline; an additional qualification in management, operations or business is advantageous.

Strong scientific foundation in tissue-based diagnostics, molecular pathology, assay development or pathology laboratory automation.

Experience

At least 15 .