OverviewWe are seeking a highly motivated NPI Specialist to support the successful introduction of new In Vitro Diagnostic (IVD) products from product development into manufacturing. The successful candidate will work closely with Research & Development, Operations, Quality, Regulatory Affairs, Supply Chain, and Product Management teams to ensure products are transferred efficiently, compliantly, and on schedule.
This is an exciting opportunity to play a key role in bringing innovative healthcare products to market while helping to improve manufacturing processes, product quality, scalability, and cost effectiveness.
ResponsibilitiesNew Product Introduction & Design Transfer - Support and coordinate design transfer activities for new and updated IVD products in accordance with ISO 13485, 21 CFR Part 820, and company quality system requirements.
- Work with cross-functional product development teams to ensure Design for Manufacturing (DfM) principles are incorporated from early development through commercialization.
- Develop and maintain design transfer documentation, plans, and deliverables.
- Support manufacturing readiness activities, including process mapping, validation planning, and risk assessments.
Manufacturing Introduction - Coordinate the transfer of new products, prototypes, and product improvements into manufacturing.
- Partner with Operations and Supply Chain teams to identify risks and opportunities associated with product launch and scale-up.
- Support pilot builds, process validation activities, and production implementation.
- Ensure projects are delivered on time, within scope, and aligned to business objectives.
Product Lifecycle Management - Support change management activities for products already on the market.
- Participate in customer complaint investigations, non-conformance investigations, and continuous improvement initiatives.
- Work with manufacturing and quality teams to implement product and process improvements.
QualificationsEducation: Degree in science related field.
Experience:Proven experience of working in an operations environment
Ability to operate under a Quality System and knowledge of Good Laboratory Practice (GLP).
Experience working in an R&D environment (pharmaceutical or medical device) would be advantageous.
Microsoft excel training or substantial experience utilizing excel is required.
Understanding of the requirements of quality management systems & applicable regulations- ISO13485 & 21CFR820
Knowledge of Non-Conformance, Change Control and CAPA systems
Competencies:SAP training or experience
Travel (If Applicable):Company DescriptionWaters Corporation (NYSE:WAT) is a global leader in life sciences and diagnostics, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, our innovative portfolio harnesses deep scientific expertise across chemistry, physics, and biology. We collaborate with customers around the world to advance the release of effective, high-quality medicines, ensure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combating antibiotic resistance. Through a shared culture of relentless innovation, our passionate team of ~16,000 colleagues turn scientific challenges into breakthroughs that improve lives worldwide.
Diversity and inclusion are fundamental to our core values at Waters Corporation. It benefits our employees, our products, our customers and our community. Waters complies with all applicable federal, state, and local laws. Qualified applicants are considered without regard to sex, race, color, ancestry, national origin, citizenship status, religion, age, marital status (including civil unions), military service, veteran status, pregnancy (including childbirth and related medical conditions), genetic information, sexual orientation, gender identity, legally recognized disability, domestic violence victim status, or any other characteristic protected by law. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. All hiring decisions are based solely on qualifications, merit, and business needs at the time.
