NPI Engineer – New Product Introduction (Level 2)
Hologic Costa Rica · Alajuela
Job description
About the role
The NPI Engineer 2 will coordinate and lead the introduction of new products and manufacturing processes at the plant, working closely with corporate and divisional teams. The role ensures compliance with FDA and ISO standards while delivering projects on time, within budget, and within scope.
Key responsibilities
- Develop reproducible, scalable, and safe manufacturing processes to support business growth.
- Validate major production process changes in line with the Quality System.
- Design, implement, and validate fixtures, tools, or specialized equipment for process changes and product launches.
- Lead structured problem‑solving activities and provide innovative technical solutions.
- Participate in project meetings with internal and external stakeholders to address process challenges.
- Collaborate with Manufacturing Engineering and CSPO to improve productivity and reduce scrap/rework.
- Analyze and execute CAPA actions related to NPI processes.
- Conduct engineering studies on materials and processes, investigate nonconformities, and implement corrective actions.
- Perform functional testing of raw materials per First Article Inspection procedures.
- Apply project management tools and best practices to ensure successful project completion.
- Train personnel on acceptance and rejection criteria for raw materials, sub‑assemblies, and finished products.
- Update quality documentation and develop new procedures to integrate new processes.
Required profile
- Bachelor’s degree in Mechanical, Electromechanical, Industrial, Materials, Chemical, Electronic Engineering or related field.
- Minimum 2 years of professional experience in a technical role (or 3 years equivalent).
- Demonstrated experience in a complex business environment and ability to work independently.
- Desirable: Project management, Lean Manufacturing, Six Sigma Green Belt, Design for Manufacturability.
Required skills
- AutoCAD
- SolidWorks
- Minitab
- Microsoft Project
- Visio
- Quality Companion
- Advanced Microsoft Office
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Published 6 hours ago
Expires 1 month from now
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Hologic Costa Rica
Alajuela
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