Manufacturing Engineer II - Catheters

Cirtec Medical - Santa Clara, CA

Full-time - Mid Level

Santa Clara, CA

Miscellaneous Manufacturing

About the position

The Manufacturing Engineer II - Catheters at Cirtec Medical is responsible for developing and implementing cost-effective manufacturing processes for catheter-based medical devices. This role involves supporting the manufacturing floor operations, improving product quality and safety, and collaborating with cross-functional teams to ensure efficient production. The engineer will also lead design transfers, manage validations, and troubleshoot processes to enhance operational efficiency.

Responsibilities

• Develops and implements robust cost-effective manufacturing processes, and improves product flow and product quality and safety performance for both sustained and new products
• Leads design transfer of new products to production including establishing assembly time and yield targets, training needs and quality control
• Develops, tests and implements tools, fixtures and equipment required for manufacturing processes
• Develops manufacturing process instructions, inspection plans and lot history travelers
• Leads creation of manufacturing process validation plans, validation protocols and reports, and implements manufacturing process validations and test method validations
• Collaborates with cross-functional teams during development phase(s), and provides inputs and recommendations for design for manufacturability (DFM)
• Develops and maintains process risk documentation (e.g. PFMEA) to identify potential risks, and implement preventive and corrective actions
• Manages and/or supports production and test equipment maintenance, qualification and calibration
• Performs analysis for cost reduction, and quality and efficiency improvement
• Prepares engineering change orders and coordinates the implementation of changes including training production staff
• Troubleshoots designs and processes when defects occur, leads investigation to determine root cause and implements effective containment and counter measures
• Dispositions non-conforming products and develops required re-work procedures
• Communicates with customers regarding process improvements and production changes

Requirements

• BS in Mechanical / Biomedical / Industrial Engineering or in an equivalent engineering discipline
• 2+ years of experience in catheter based medical device process development and/or manufacturing engineering
• Experience with new product introduction
• Solid knowledge of GMP and ISO 13485 regulations
• Must be able to review and interpret technical drawings and specifications
• Strong computer skills, including the MS Office suite
• Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral
• Must have demonstrated organizational skills to manage multiple priorities and schedules

Nice-to-haves

• Experience with lean manufacturing techniques, value stream mapping, and continuous improvement methodologies
• Proficiency in Solidworks

Benefits

• Training and career development
• Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid Time Off
• 401(k) retirement savings with a company match