Engineer II, AME

ICU Medical; Tijuana; Presencial; MXN 915,000 - 1,283,000; Jornada completa

Descripción de la vacante

A medical device manufacturing company in Tijuana is looking for an engineer who conducts process validation activities related to design transfer and manufacturing improvements. The role involves collaborating with various teams, supporting sample builds, and ensuring compliance with safety procedures. Candidates must have a Bachelor's engineering degree and 3-5 years of relevant experience.

Formación

• Must be at least 18 years of age.
• Bachelor’s engineering degree from an accredited college or university is required.
• 3-5 Years of experience.

Responsabilidades

• Conducts process validation activities related to design transfer.
• Supports sample builds and the development of local Work Instructions.
• Validates development tools and compiles metrics and engineering data.
• Troubleshoots production line issues.
• Ensures safety procedures are followed.

Conocimientos

Analytical skills

Problem solving

Project management

Communications

Multitasking

Organizational skills

Attention to detail

Planning skills

Leadership skills

Educación

Bachelor’s engineering degree

Descripción del empleo

Position Summary

Conducts process validation activities related to design transfer and manufacturing improvement projects. Supports strategic initiatives such as CAPAs, remediations, and continuous improvement. Collects BOMs, drawings, and work instructions from Agile for product transfers, including translations.

Essential Duties & Responsibilities

• Works with the Advanced Manufacturing Engineering team to understand and localize production processes and test requirements.
• Supports sample builds and the development of local Work Instructions.
• Supports and/or owns Design Verification and Process Validation build preparation for New Product Introduction (NPI) projects, or as part of CAPA investigations and corrective actions.
• Validates development tools of moderate complexity and compiles metrics and engineering data, including validation testing outputs.
• Supports verification and validation protocols issued under NPI projects.
• Supports and/or leads process validation activities per Master Validation Plans (IQ, Process Characterization, TMVs, CSV, OQ, and PQ), as well as BOM creation, manufacturing procedures, and product unit cost definition.
• Troubleshoots production line issues, including performing root cause analysis for product, equipment, and system failures.
• Collaborates with internal departments, vendors, and equipment suppliers to resolve issues and coordinate efforts in support of business objectives.
• Ensures safety procedures are followed and leads by example.
• Performs various industrial engineering technical tasks of intermediate scope and complexity, under limited supervision from the direct supervisor or engineering staff.
• Ensures Company operations comply with all applicable laws, regulations, standards, good business practices, and internal procedures (including knowledge of relevant industry standards, occupational health, safety, and environmental regulations).

Knowledge & Skills

• Good analytical, problem solving and project management skills
• Ability to work in a geographically diverse business environment
• Ability to leverage and/or engage others to accomplish projects
• Good verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Multitasks, prioritizes and respects deadlines. Good organizational and follow-up skills, as well as attention to detail
• Site best practices (routings, manufacturing layouts, validations)
• Process Validations
• Good planning skills
• Data driven decision-making skills
• Good leadership skills

Minimum Qualifications, Education & Experience

• Must be at least 18 years of age
• Bachelor’s engineering degree from an accredited college or university is required. Education requirements can be obtained through an educational institution or gained through equivalent work experience.
• +3-5 Years of experience.
• Demonstrated experience with lean principles

Only candidates who meet all the requirements will be considered for an interview.