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Senior NPI Engineer
| Reference: | JCAO2909 | Location: |
Dublin |
| Qualification: | Degree | Experience: | 5-7 Years |
| Job Type: | Permanent | Salary: | Not Disclosed |
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 [email protected] or call in confidence 086 0204322
Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
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