Senior NPI Engineer

Location: Dublin (On-site)
Employment Type: Permanent, Full-time

This is a significant opportunity for an experienced engineer to join a scaling medical device startup in Dublin. Our client is currently advancing a medical device through critical development phases, including design verification and clinical trials. As a Senior NPI Engineer, you will play a pivotal role in bridging the gap between design development and commercial-scale manufacturing, ensuring that innovative life-saving technology reaches patients with the highest standards of quality and efficiency.

Role Overview

Reporting to the NPI Manager, you will be responsible for the end-to-end manufacturing strategy for this complex medical device. This involves everything from initial process development and tooling implementation to managing contract manufacturing partnerships and navigating regulatory approvals. You will be a key technical lead in ensuring the production environment is robust, compliant, and capable of meeting ambitious clinical and commercial timelines.

Key Responsibilities
- Lead day-to-day production management to ensure the company build plan is met on schedule.
- Develop and refine manufacturing processes, providing hands-on training to technicians and operators to ensure process consistency.
- Source and implement specialised tooling, instruments, and advanced technologies required for device assembly.
- Manage complex projects with a focus on cross-functional alignment, budget adherence, and strict project timelines.
- Create and maintain comprehensive technical documentation, including Material Specifications, Production Instructions, BOM, DHR, and DMR, in accordance with regulatory standards.
- Design and execute Design of Experiments (DOEs) to characterise process parameters and establish robust operating windows.
- Mitigate manufacturing risks through the application of risk controls, process FMEAs, and rigorous measurement methods.
- Lead process validation activities, including IQ, OQ, PQ, TMV, and software validation.
- Collaborate closely with contract manufacturers to transfer processes and optimise production layouts.
- Support the Quality department regarding inspection standards, CAPA, and NCR resolution.
- Drive continuous improvement initiatives focused on enhancing yield, capacity, and overall manufacturing efficiency.

Skills and Experience

- A minimum of 5 to 10 years of experience within the medical device industry is essential.
- Proven expertise in New Product Introduction (NPI) or Process Development within a highly regulated environment.
- Deep technical knowledge of validation protocols (IQ/OQ/PQ) and statistical methods like DOE.
- Strong familiarity with quality management systems, including GMP, ISO 13485, and FDA requirements.
- Exceptional organisational skills with the ability to manage multiple workstreams simultaneously.
Essential Requirements
- B.S. or Masters degree in Mechanical Engineering, Biomedical Engineering, or a related technical discipline.
- Demonstrable experience in preparing high-quality technical documentation for regulatory submissions.
- Excellent communication skills, with the ability to lead and influence cross-functional teams.
Desirable Requirements
- Previous experience working with cardiovascular implants.
- Experience managing external contract manufacturing organisations (CMOs).

Application Process
If you are a driven engineer looking to make a tangible impact on patient outcomes, please submit your CV for consideration to james.cassidy@lifescience.ie or call in confidence 086 0204322