Senior Engineer Product Transfer (18 months contract)

Posted:
11/17/2024, 4:00:00 PM

Location(s):
Baja California, Mexico ⋅ Tijuana, Baja California, Mexico

Experience Level(s):
Senior

Field(s):
Product

Work Flexibility: Onsite

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 will need:

Required

  • Bachelor’s degree in an engineering discipline

  • 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

Travel Percentage: 10%