Sr. Manufacturing Engineer; Catheters

Description

This position is located on-site in Santa Clara, California.

Please note that sponsorship or transfer of sponsorship is not available for this role.

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.

• Develop and implement robust cost-effective manufacturing processes, and improve product flow, quality, and safety performance for both sustained and new products.
• Lead design transfer of new products to production, including establishing assembly time and yield targets, training needs, and quality control.
• Develop, test and implement tools, fixtures and equipment required for manufacturing processes.
• Create manufacturing process instructions, inspection plans and lot history travelers.
• Lead creation of manufacturing process validation plans, validation protocols and reports, and implement manufacturing process validations and test method validations.
• Collaborate with cross-functional teams during development phases, and provide inputs and recommendations for design for manufacturability (DFM).
• Develop and maintain process risk documentation (e.g., PFMEA) to identify potential risks, and implement preventive and corrective actions.
• Manage and/or support production and test equipment maintenance, qualification and calibration.
• Perform analysis for cost reduction, and quality and efficiency improvement.
• Prepare engineering change orders and coordinate the implementation of changes including training production staff.
• Troubleshoot designs and processes when defects occur, lead investigation to determine root cause and implement effective containment and counter measures.
• Disposal of non-conforming products and develop required re-work procedures.
• Communicate with customers regarding process improvements and production changes.
• Perform other responsibilities duties as assigned.

• BS in Mechanical / Industrial Engineering or 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 Solid Works 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 possess excellent communication skills, both written and oral.
• Must have demonstrated organizational skills to manage multiple priorities and schedules.

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.

Cirtec Medical Corporation considers everyone for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all its related companies fully endorse equal opportunity. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create an…