Manufacturing Engineer II (Catheter)

Cirtec Medical - Santa Clara, CA

Full-time - Mid Level

Onsite - Santa Clara, CA

Miscellaneous Manufacturing

About the position

Cirtec Medical Corporation is seeking a Manufacturing Engineer II to join our dynamic engineering team in Santa Clara, California. This position is integral to our operations, focusing on catheter-based devices. As a Manufacturing Engineer II, you will be responsible for maintaining, developing, and implementing cost-effective manufacturing processes and methods. You will provide day-to-day support for the catheter manufacturing floor operations from an engineering perspective, ensuring that our processes are efficient and effective. Your role will involve documenting processes, implementing innovative ideas and solutions to improve assembly operations, and reducing costs. You will also be tasked with developing tooling and fixturing, as well as driving investigations tied to non-conformances. Experience with validations, risk management, and Lean Principles is preferred, as these skills will be crucial in your day-to-day responsibilities. In this role, you will collaborate closely with cross-functional teams, including Operations, R&D, and Purchasing, to ensure that new products are designed for manufacturability and that existing products are continuously improved. You will lead the design transfer of new products to production, establishing assembly time and yield targets, and identifying training needs and quality control measures. Your responsibilities will also include developing manufacturing process instructions, inspection plans, and lot history travelers, as well as leading the creation of manufacturing process validation plans and protocols. You will be expected to manage and support production and test equipment maintenance, qualification, and calibration, and perform analyses for cost reduction and quality improvement. This position requires a proactive approach to troubleshooting designs and processes when defects occur, leading investigations to determine root causes, and implementing effective containment and corrective measures. You will also be responsible for communicating with customers regarding process improvements and production changes, ensuring that we maintain high standards of quality and efficiency in our operations. This is not a remote position, and you will be expected to work on-site in our clean and well-lit production areas.

Responsibilities

• Develop and implement robust cost-effective manufacturing processes, improving product flow and quality.
• Lead design transfer of new products to production, establishing assembly time and yield targets.
• Develop, test, and implement tools, fixtures, and equipment for manufacturing processes.
• Create manufacturing process instructions, inspection plans, and lot history travelers.
• Lead creation of manufacturing process validation plans, protocols, and reports.
• Collaborate with cross-functional teams to provide inputs for design for manufacturability (DFM).
• Maintain process risk documentation (e.g., PFMEA) and implement preventive actions.
• Manage and support production and test equipment maintenance, qualification, and calibration.
• Perform analysis for cost reduction and quality improvement.
• Prepare engineering change orders and coordinate implementation of changes.
• Troubleshoot designs and processes, leading investigations to determine root causes.
• Communicate with customers regarding process improvements and production changes.

Requirements

• BS in Mechanical/Biomedical/Industrial Engineering or equivalent discipline.
• 2+ years of experience in catheter-based medical device process development and/or manufacturing engineering.
• Experience with lean manufacturing techniques and continuous improvement methodologies preferred.
• Solid knowledge of GMP and ISO 13485 regulations.
• Ability to review and interpret technical drawings and specifications; proficiency in Solidworks preferred.
• Strong computer skills, including MS Office suite.
• Fluent in English with excellent communication skills, both written and oral.
• Demonstrated organizational skills to manage multiple priorities and schedules.

Nice-to-haves

• Experience with new product introduction.
• Proficiency in Solidworks.

Benefits

• Paid time off
• 401(k) retirement savings with a company match
• Training and career development programs
• Tuition assistance
• Health care and well-being programs including medical, dental, vision, and wellness programs
• Clean and well-lit production areas
• Competitive compensation and incentives.