Manufacturing Process Specialist

hace 3 semanas


Tijuana, Baja California, México Stryker Group A tiempo completo

Job Summary:

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This role involves supporting the Surgical Stryker Sustainability Solutions Business in Transfer and Post-Launch activities, with a focus on a specific project to ensure business stability.

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Key Responsibilities:

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  • Evaluate manufacturing outcomes and implement continuous improvements and cost efficiencies">
  • Support New Product Introductions (NPI) and new equipment/process introductions, increasing capacity, reducing scrap, improving yield, enhancing safety, monitoring existing processes, and identifying and implementing process improvements within a regulated medical device reprocessing environment">
  • Apply Statistical, Lean, GMP, and Six Sigma methodologies to support and improve existing processes, ensuring they align with the project's scope and objectives">
  • Manage the effective transfer of new products, design changes, or line-extended devices to production, focusing on Transfer and Post-Launch activities">
  • Foster a culture of continuous improvement by collaborating with cross-functional teams and providing project-specific support across all functional areas">
  • Conduct Failure Analyses (FAs) and implement enhancements to improve the functionality, performance, and reliability of medical devices">
  • Optimize manufacturing processes by implementing process improvements, reducing scrap rates, enhancing machining operations, and ensuring compliance with safety standards">
  • Develop and execute technical protocols, generate comprehensive reports documenting project milestones, and implement clear operating procedures, including standard work and visual work instructions">
  • Train production staff on new product launches and design changes, ensuring smooth transitions and alignment with project requirements">
  • Gain and apply in-depth knowledge of FDA/ISO standards, including Design Control, to ensure compliance and support the successful execution of medical device projects">
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Requirements:

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  • B.S. in Engineering (Industrial, Mechanical, Electrical or related)">
  • Minimum 2 years of experience as Manufacturing Engineer in a highly regulated industry, preferably in a Medical Devices company">
  • Experience with development of protocols for process validation">
  • Knowledge of One PLM, Valgenesis and SAP systems is a plus">
  • Knowledge of AutoCAD is desirable">
  • Basic computer skills (word processing, spreadsheets, database)">
  • Conversational English">
  • Problem solving skills">
  • Availability to work on a 14 months contract">
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Estimated Salary: $120,000 - $180,000 per year

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Location: [Undisclosed]



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