Senior NPI Specialist

Overview

We 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.

Responsibilities

New 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.

Qualifications

Education: 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):