NPI Engineer

hace 1 semana

Mexicali BC, México Sonova A tiempo completo
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 13485, 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.

Experiencia y requisitos

Qualifications & Skills:

  • Bachelor's degree in Industrial, Mechanical, or Electrical Engineering.
  • Solid knowledge of FDA QSR regulations; experience with ISO 13485 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

  • Beneficios 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

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