Descripción y detalle de las actividades- The NPI Engineer is responsible for planning, coordinating, and executing the introduction of new products, ensuring compliance with all regulatory, quality, and manufacturing requirements (ISO *****, FDA, etc).
This role bridges the gap between product development and full-scale manufacturing, ensuring that designs are efficiently transferred into production with validated processes, robust documentation, and full regulatory traceability.
-- Participate in internal and external audits, preparing documentation, validation protocols, and technical reports.
- Lead the implementation of new products into manufacturing, ensuring process readiness and compliance.
- Manage product and technology transfers from R&D; or other production sites, ensuring smooth handover and scalability.
- Lead cross-functional projects involving NPIs, layout changes, capacity expansion, and continuous improvement.
- Define project scopes, timelines, resource needs, and communicate progress to stakeholders.
- Manage engineering change orders (Changes Plans) ensuring proper implementation and document updates.
- Identify and drive continuous improvement initiatives within manufacturing and transfer processes.
- Fully manages and/or participates in implementation of new equipment and processes, on-site validation (IQ/OQ/PQ), training of necessary staff and updating process documentation.Experiência y requisitos- **Qualifications & Skills**:- Bachelor's degree in Industrial, Mechanical, or Electrical Engineering.
- Solid knowledge of FDA QSR regulations; experience with ISO ***** standards is strongly preferred.
- Minimum of 5 years of experience in a similar manufacturing or NPI engineering role.
- Proven experience creating and maintaining process work instructions for manufacturing operations,



including assembly and in-process acceptance procedures.
- Proficient in developing and executing Process Validation Protocols and/or Transfer Plans, including generating comprehensive test reports.
- Skilled in process risk assessments, including pFMEA development and maintenance.
- Supports investigation, disposition, and implementation of corrective actions for non-conforming materials.
- Experience establishing and monitoring statistical process controls (SPC) in production environments.
- Strong attention to detail and ability to work independently or collaboratively in cross-functional teams.
- Demonstrated problem-solving abilities with a structured and data-driven approach.
- Proficient in Microsoft Office Suite; working knowledge of Corel Draw.
-- **Soft Skills & Competencies**:- High learning agility and adaptability to new challenges.
- Strong interpersonal skills with the ability to collaborate effectively and respectfully in diverse teams.
- Able to present ideas clearly, actively listen, and contribute to group decision-making.
-- **Additional Responsibilities**:- Participate in the design or redesign of tools and equipment to improve manufacturing processes.
- Ensure employee safety and compliance with health and safety regulations.
- Monitor, test, and maintain production equipment to ensure operational efficiency.
- Collect and analyze production data for continuous improvement.
- Support cost control initiatives and contribute to maintaining operations within budget.Beneficios- Ventajas de acuerdo a la LFT- fondo de ahorro-- **Número de vacantes** 2- ** Área** Ingeniería- ** Contrato** Permanente- ** Modalidad** Presencial- ** Turno** Diurno- ** Jornada** Tiempo Completo-- **Horario**- Tiempo completo- Lunes a viernes-- **Estudios** Carrera con título profesional- ** Inglés**Hablado: Avanzado, Escrito: Avanzado- ** Edad** ******* años- ** Disponibilidad p.viajar** No

📌 Npi Engineer (Mexicali)
🏢 Sonova
📍 Mexicali