Lead Manufacturing Engineer

1 week ago


California, United States Cypress HCM Full time

Position Overview

Cypress HCM is seeking a highly skilled Senior Manufacturing Engineer to join our dynamic team. This role is essential for driving innovation and enhancing the efficiency of our catheter-based device manufacturing processes.

Key Responsibilities

  • Design and implement effective manufacturing processes that optimize product flow, quality, and safety for both existing and new products.
  • Oversee the transition of new products into production, including setting assembly time and yield targets, identifying training requirements, and ensuring quality control measures are in place.
  • Develop, test, and deploy necessary tools, fixtures, and equipment to support manufacturing operations.
  • Create detailed manufacturing process instructions, inspection plans, and documentation for lot history.
  • Lead the development of manufacturing process validation plans, including protocols and reports, and ensure compliance with validation standards.
  • Collaborate with cross-functional teams during product development to provide insights and recommendations for design for manufacturability (DFM).
  • Maintain and update process risk documentation (e.g., PFMEA) to identify potential risks and implement preventive measures.
  • Support the maintenance, qualification, and calibration of production and testing equipment.
  • Conduct analyses aimed at reducing costs while improving quality and efficiency.
  • Prepare engineering change orders and manage the implementation of changes, including training for production staff.
  • Investigate defects in designs and processes, determine root causes, and implement effective corrective actions.
  • Manage non-conforming products and develop necessary rework procedures.
  • Engage with customers to discuss process improvements and production modifications.

Qualifications

  • Bachelor's degree in Mechanical or Industrial Engineering, or a related engineering field.
  • A minimum of 5 years of experience in catheter manufacturing or process development.
  • Experience in the medical device manufacturing sector is highly desirable.
  • Familiarity with lean manufacturing principles, value stream mapping, and continuous improvement methodologies is preferred.
  • Strong understanding of GMP and ISO 13485 standards.
  • Proficiency in Solidworks and the ability to interpret technical drawings and specifications.
  • Excellent computer skills, particularly with the MS Office suite.
  • Fluency in English, with strong written and verbal communication skills.
  • Demonstrated ability to manage multiple priorities and maintain organizational effectiveness.

Compensation

The salary range for this position is $120,000 - $150,000 annually, plus bonus opportunities.



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