NPI Engineer
3 days ago
We are partnering with a leading company in the medical device industry to recruit a New Product Introduction (NPI) Engineer. In this role, you will play a pivotal role in guiding the introduction of new products and driving product development projects from concept to commercialization. This is an exciting opportunity to contribute to innovation and excellence within a dynamic, collaborative environment.
Key Responsibilities:
1. Lead and manage NPI and Product Development (PD) activities, ensuring smooth project execution.
2. Support the implementation of ISO56000, Innovation Management Standard.
3. Oversee design and development of new products, working closely with customers throughout their design process.
4. Drive prototyping, testing, and initial engineering builds, ensuring design verification and validation.
5. Conduct risk assessments and manage risk in accordance with ISO13485 standards.
6. Develop and validate test methods and processes using statistical tools (e.g., R&R, DOE).
7. Manage project lifecycle, including budgeting, prioritization, resource allocation, and stakeholder communication.
8. Identify and integrate new technologies to enhance product and process robustness.
Essential Requirements:
1. NFQ Level 8 or higher in a technical discipline (Mechanical, Manufacturing, Mechatronics, or Biomedical Engineering).
2. Proven experience in NPI, product and process validation, and project management methodologies (e.g., PMBOK, Agile).
3. Strong communication skills, with the ability to engage effectively with stakeholders at all levels.
4. Six Sigma certification and demonstrated ability to lead process improvement initiatives.
5. Experience in grinding, moulding, EDM, and/or laser processes is a distinct advantage.
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