What are the responsibilities and job description for the Vice President of Product Development, Diagnostics - US position at Hartmann Young?
VP, Product & Process Development
Overview
Senior R&D leadership role within an innovative life sciences/diagnostics company. Responsible for advancing the product pipeline, improving laboratory and operational processes, and driving digital innovation initiatives. Reports into the Chief Scientific Officer and plays a key role in company strategy and execution.
Core Responsibilities
- Lead and oversee product (assay) development and validation across the full lifecycle
- Drive process engineering and continuous improvement within a regulated lab environment (e.g. CLIA/CAP)
- Manage digital innovation initiatives, including AI-enabled pathology solutions
- Own R&D project portfolio, timelines, budgets, and resource allocation
- Lead cross-functional collaboration with Regulatory, Medical Affairs, and Commercial teams
- Support and contribute to regulatory submissions (e.g. FDA 510(k), De Novo, CE mark)
- Oversee validation studies, compliance, and SOP development
- Manage external partnerships and research collaborations
- Build, mentor, and scale high-performing R&D and engineering teams
- Contribute to IP strategy and innovation roadmap
Functional Oversight
- Product development (assays/diagnostics)
- Process development & lab optimisation
- Digital / AI innovation
- R&D lab operations supporting external research
Key Requirements
- 15 years in life sciences, diagnostics, or medical devices
- 5 years in senior leadership roles
- Strong experience in:
- Assay development & validation
- Regulated environments (CLIA, CAP, ISO)
- FDA submissions (510k, De Novo)
- Process engineering / operational improvement
- Proven ability to lead complex, cross-functional R&D programs
- Experience managing teams, budgets, and project portfolios
- Strong analytical, problem-solving, and execution skills
Education
- Master’s or PhD in engineering, biosciences, or related field