Sr. Manufacturing Engineer (Catheter)

Cirtec Medical-posted 2 months ago

$100,000 - $150,000/Yr

Full-time • Senior

Santa Clara, CA

101-250 employees

Miscellaneous Manufacturing

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For over three decades, Cirtec Medical has been a leading provider of manufacturing solutions for complex Class II and III medical devices. We specialize in providing comprehensive services from design and development to manufacturing and finished device assembly. Our expertise spans active implants and neuromodulation, interventional cardiology, structural heart, minimally invasive surgical systems, smart orthopedics, and precision components. Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenge, you may be a perfect fit for our team! We are actively looking for a Senior Manufacturing Engineer who can bring innovation and creative thinking to the team on catheter-based devices. As a Senior Manufacturing Engineer, you will be primarily responsible for maintaining, developing, and implementing cost-effective manufacturing processes and methods. You will provide day to day support of the catheter manufacturing floor operations from an engineering perspective. Senior Manufacturing Engineers document processes, implement ideas and solutions to improve assembly operations and reduce costs, develop tooling/fixturing, drive investigations tied to non-conformances. Experience with validations, risk management, and Lean Principles is preferred.

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
Perform other responsibilities duties as assigned.

BS in Mechanical / Industrial Engineering or in an equivalent engineering discipline
5+ years of experience in catheter manufacturing/process development
Experience in medical device manufacturing
Experience with lean manufacturing techniques, value stream mapping, and continuous improvement methodologies preferred
Solid knowledge of GMP and ISO 13485 regulations
Must be proficient in Solidworks and must be able to 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

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

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Sr. Manufacturing Engineer (Catheter)

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