Overview
An exciting opportunity to become part of a dynamic team responsible for the R&D of IVD products. The team handles activities including analytical development, product development, verification, validation, transfer to operations, and on-market support of Clinical IVD products.
Responsibilities
* Lead technical feasibility assessments for new products and methods, including prototype development, manufacturing processes, QC processes, and stability evaluations.
* Transfer methods from research teams, assess their robustness, and validate them.
* Design experiments for assay development to meet design goals.
* Plan and conduct verification and validation studies for IVD products.
* Produce Product Specification and Requirements documentation; guide development teams.
* Author reports to meet regulatory requirements (IVDR, FDA).
* Collaborate with stakeholders to achieve project goals, manage risks, and meet timelines.
* Participate in design reviews, FMEAs, phase reviews, and other project activities.
* Develop verification documents demonstrating compliance with regulatory standards.
* Perform additional duties professionally as assigned.
* Complete Quality System actions promptly, such as CAPA, NCR.
Qualifications
Education: Degree in a scientific subject with a strong chemistry component or equivalent industry experience.
Experience: Proven laboratory experience with analytical equipment (HPLC, UPLC, LC/MS/MS advantageous). Knowledge of design control in regulated environments (8+ years preferred). R&D experience in pharma or medical devices and familiarity with statistical tools are desirable.
Competencies
* Strong communication skills for reporting and requirements writing.
* Ability to work independently and collaboratively across levels.
Travel
International travel for training, method transfer, clinical sites, and conferences as needed.
Company Description
Waters Corporation is a global leader in measurement sciences, innovating in chromatography, mass spectrometry, and thermal analysis for over 60 years. With a diverse workforce and operations worldwide, we focus on advancing healthcare, environment, food safety, and water quality. We promote diversity, inclusion, and equal opportunity in our workplace.
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