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Cirtec Medical · 9 hours ago

Sr. Manufacturing Engineer (Catheters)

Santa Clara, CA

Full-time

Onsite

Senior Level

$100K/yr - $150K/yr

5+ years exp

Cirtec Medical is a leading provider of manufacturing solutions for complex Class II and III medical devices. They are seeking a Senior Manufacturing Engineer to innovate and enhance manufacturing processes for catheter-based devices, providing engineering support to the manufacturing floor and ensuring product quality and efficiency.

ManufacturingMedical Device

No H1B

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

Perform other responsibilities duties as assigned

Qualification

Catheter manufacturing experienceLean manufacturing techniquesGMPISO 13485 knowledgeSolidworks proficiencyProcess validation experienceCommunication skillsOrganizational skills