Ensuring the successful design and development of new products through collaboration with cross-functional teams
Supporting development of design control records including design and development planning, risk management files, Verification & Validation (V&V) plans, requirement traceability matrices, etc.
Maintaining Design & Development File (DDF) and ensuring its accuracy
Coordinating and leading design review meetings and design changes
Contributing to and maintaining the risk management file with input from development teams
Identifying and implementing process improvements to establish standardized best practices
Working across Agilent divisions to draft and provide input to Agilent global documentation and processes
Supporting and contributing to internal and external audits
Working on problems of diverse scope, ensuring alignment and consistency wherever possible
Exercising judgment within generally defined practices and policies to problem-solve when faced with complex challenges

Bachelor’s degree (BS) or advanced degree in biological sciences
Minimum 3+ years relevant experience (product development/assay development/IHC/ISH)
Strong writing skills
High attention to detail
Presentation skills (internal and external)
Excellent communication and teamwork
Ability to work independently
Understanding of design control regulations and documentation requirements
Knowledge in: Immunohistochemistry, In situ hybridization, Cell biology, Molecular biology
Experience in the diagnostics industry

Design Control Specialist, Intermediate

Key skills