Senior Engineer Product Transfer (12 months contract)

Stryker; Tijuana; Presencial; MXN 557,000 - 930,000; Jornada completa

Descripción de la vacante

A leading company in medical devices is seeking a Senior Engineer in Tijuana, Mexico, focused on executing engineering tasks related to product transfers and new introductions. The role requires strong adherence to regulatory compliance and quality assurance in a fast-paced environment.

Formación

• Minimum of 4 years experience in product introduction or transfer roles.
• Advanced level of English required.
• Experience in an FDA regulated or highly regulated industry.

Responsabilidades

• Execute engineering tasks for product transfers or new product/process introductions.
• Create PFMEA, Control Plans, and Work Instructions.
• Ensure GMP and safety compliance, train manufacturing staff.

Conocimientos

Problem Solving

Documentation

Regulatory Compliance

Quality Assurance

Educación

Bachelor’s degree in an engineering discipline

Descripción del empleo

What you will do-

• Execute engineering tasks for product transfers or new product/process introductions, ensuring adherence to Stryker procedures and complete documentation.

• Maintain the quality of processes and products as per operation and material specifications specific to the project.

• Support the selection of components and equipment through evaluation of specifications, reliability, safety, and relevant regulatory requirements.

• Contribute to capital acquisition activities, including specifying, installing, and validating equipment within project parameters.

• Perform equipment analyses, conduct tests, and review results, participating in process review meetings.

• Create PFMEA, Control Plans, Work Instructions, and related manufacturing documents for the project.

• Develop PPAP and perform process capability studies for product transfers and launches.

• Ensure GMP, safety compliance, conduct MSA studies, train manufacturing staff, and interact with global teams to meet project goals.

What you need-

Required

• Bachelor’s degree in an engineering discipline.

• Minimum of 4 years of experience as Sr. Engineer on new product introduction or product transfer roles.

• Experience in an FDA regulated or highly regulated industry.

• Advanced level of English.

Preferred

• Six Sigma Yellow belt or higher certification.

• Experience in the Medical Devices industry.