Sr. Manufacturing Engineer (Catheters)

About the role

This position is located on-site in Santa Clara, California. Please note that sponsorship or transfer of sponsorship is not available for this role.

Key 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
• Ledesign 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
• Ledesigns and maintains 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
• Disposes non-conforming products and develops required re-work procedures
• Communicates with customers regarding process improvements and production changes

Qualifications

• Must have a BS in Mechanical / Industrial Engineering or in an equivalent engineering (STEM) discipline
• 5+ years of experience in catheter manufacturing/process development
• Experience in medical device manufacturing (CMO or CDMO preferred)
• Experience with lean manufacturing techniques, value stream mapping, and continuous improvement methodologies
• Solid knowledge and working familiarity of GMP and ISO 13485 regulations
• Proficiency in SolidWorks with the ability 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
• Demonstrated organizational skills to manage multiple priorities and schedules

Pay

The pay range for this job is $115,000 – $155,000 per year. The successful candidate’s starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions. The expected base pay range for this role may be modified based on market conditions.