06 Aug
|
Genetic Signatures
|
Inner West Council
06 Aug
Genetic Signatures
Inner West Council
Genetic Signaturesimprovespatient care and outcomes by developing innovative diagnostic technologies that simplify molecular pathology. We are an Australian-based manufacturer supplying leading pathology laboratories locally and globally, and we continue to grow our diverse,supportiveand high-performing team.
We are seeking an experienced and strategic Head of Product Development to lead the end-to-end delivery of innovative diagnostic products. This onsite, full time role (38 hours per week) is responsible for driving product development activities across research, assay development, and system integration, ensuring the successful progression of projects from concept through to verification, validation, regulatory submission, and commercial launch.
In this role you willbe responsible for:
- Lead end-to-end product development planning and execution aligned to CTO-approved technology strategy.
- Oversee research, assay development, systemintegrationand technical documentation activities.
- Manage priorities, resources, risks, timelines,budgetsand cross-functional dependencies.
- Provide leadership to the Development Lead, ResearchLeadand System Integration Lead.
- Coordinate outsourced partners,vendorsand technical service providers.
- Ensure development outputs support design control, verification, validation and regulatory requirements
To be successful as ourSenior Laboratory Technician, you willpossess:
- Minimum 10 years' experience in molecular diagnostics, IVD, biotechnology,medtechor regulated life sciences.
- At least 5 years' leadership experience in product development, R&D;, systemintegrationor technical delivery.
- Experience within an ISO 13485-aligned or medical device environment.
- Strong knowledge of design control, risk management,verificationand validation activities.
- Excellent stakeholder management, leadership,communicationand decision-making skills.
- Experience supporting regulatory submissions, product launchreadinessand post-market activities.
Qualifications & Experience:
- Postgraduate qualification (Honours,master'sor PhD) in a relevant scientific, engineering or technology discipline.
- Project Management certification (PMP, PRINCE2 or equivalent)advantageous.
- Experience presenting technical information to executives,boardor external scientific audiences.
Genetic Signatures Ltd is committed toprovidingequal employment opportunities. We thrive on the diversity of thought that comes through our workforce and encourage anyone withtalentand drive to better healthcare outcomes to apply.
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📌 Head of Product Development (Inner West Council)
🏢 Genetic Signatures
📍 Inner West Council