Sr. Manufacturing Engineer; Catheters

Overview

Position:
Senior Manufacturing Engineer – On-site (Santa Clara, California). Sponsorship or transfer of sponsorship is not available.

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, spanning active implants, neuromodulation, interventional cardiology, structural heart, minimally invasive surgical systems, smart orthopedics, and precision components. Our dedicated teams prioritize growth, innovation, and collaboration, actively seeking opportunities to improve client support.

We are actively looking for a Senior Manufacturing Engineer who can bring innovation and creative thinking to the team on catheter-based devices. The role focuses on maintaining, developing, and implementing cost‑effective manufacturing processes and methods, supporting day‑to‑day catheter manufacturing floor operations from an engineering perspective. The Engineer will document processes, implement improvement ideas, develop tooling/fixtures, drive investigations tied to non‑conformances, and bring experience with validations, risk management, and Lean Principles.

• Develop, implement, and continuously improve robust, cost‑effective manufacturing processes, enhancing product flow, quality, and safety for existing and new products.
• Lead design transfer of new products to production, establishing assembly time and yield targets, training needs, and quality control requirements.
• 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, protocols, and reports; implement process and test method validations.
• Collaborate with cross‑functional teams during development phases, providing 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/efficiency improvement.
• Prepare engineering change orders and coordinate implementation, including training production staff.
• Troubleshoot designs and processes when defects occur, lead investigations to determine root cause, and implement effective containment and countermeasures.
• Dispositions non‑conforming products and develop required re‑work procedures.
• Communicate with customers regarding process improvements and production changes.
• Perform other responsibilities and duties as assigned.

• BS in Mechanical, Industrial Engineering, or an equivalent 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 with 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.
• Excellent written and oral communication skills; fluent English required.
• Strong organizational skills to manage multiple priorities and schedules.

The pay range for this job is $115,000 – $155,000 per year. The 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.