Senior Mechanical Design Engineer (Catheter Development)

Cirtec - Santa Clara, CA

Full-time - Mid Level

Onsite - Santa Clara, CA

Publishing Industries

About the position

As a Senior Mechanical Design Engineer at Cirtec, you will be an integral part of a dynamic engineering team focused on the development of innovative catheter-based medical devices. This position requires a blend of creativity and technical expertise, as you will lead product development teams through various phases, from concept feasibility to detailed design and verification. Your role will involve defining product requirements, creating design specifications, and ensuring compliance with applicable regulatory standards. You will be responsible for generating and maintaining computer-aided drawings (CAD) using SolidWorks, as well as documenting mechanical designs through schematics and component specifications. In this position, you will drive hands-on fabrication and testing of prototypes, utilizing bench testing, animal studies, and cadaver studies to evaluate product designs. You will also perform detailed design reviews and tolerance analyses to meet performance, cost, reliability, and manufacturability requirements. As the main technical contact with customers, you will communicate project needs and present technical updates, risks, and issues. Your ability to effectively interface with suppliers will be crucial in fabricating both prototype and final components. Additionally, you will develop test plans and protocols, execute prototype testing, and lead the creation of risk management documentation, including Failure Mode and Effects Analysis (FMEA). You will create engineering-level manufacturing process instructions and related documentation, while proactively anticipating technical risks and formulating mitigation strategies. Collaboration with cross-functional team members is essential to maintain the Design History file in compliance with FDA Design Control and ISO 13485 requirements. Mentoring and guiding other engineers and technicians will also be part of your responsibilities, ensuring knowledge transfer and skill development within the team.

Responsibilities

• Lead product development of complex catheter based medical devices through various phases of concept feasibility, detailed design and verification
• Lead creation of product requirements and design specifications, and determine applicable regulatory standards and ensures appropriate integration into product requirements
• Generate and maintain computer-aided drawings (CAD) using SolidWorks, schematics and component specifications to document mechanical designs
• Drive hands-on fabrication and testing of prototypes using bench testing, animal and/or cadaver studies to evaluate product designs, and recommend and implement design modifications
• Perform detailed design reviews and tolerance analyses to achieve product performance, cost, reliability and manufacturability requirements
• Serve as the main technical contact with customers and communicate directly with customers to understand project / product needs, and present technical updates, risks and issues
• Effectively interface with and manage suppliers to fabricate prototype and final components
• Develop test plans and protocols, and executes prototype testing and design verification testing
• Lead and contribute towards creation of risk management documentation, including FMEAs
• Create engineering-level manufacturing process instructions, bill of materials and related manufacturing documentation
• Proactively anticipate technical risks and issues, and formulate and implement risk mitigations and corrective/preventive actions
• Assist program managers in developing and maintaining project plans, and in tracking program health in terms of schedule, budget, and technical risks and issues
• Collaborate with cross-functional team members to create and maintain Design History file per internal company procedures, FDA Design Control (21 CFR 820) and ISO 13485 requirements
• Mentor and provide guidance to other engineers and technicians
• Other duties as assigned

Requirements

• BS in Mechanical / Biomedical Engineering with minimum 5 years of experience within the Medical Device industry
• Minimum of 3 years developing and designing catheters
• Extensive knowledge and experience with product development of catheter based medical devices
• Strong understanding of catheter manufacturing (i.e. braiding, extrusions, material selections, balloons, etc.)
• Hands on experience with catheter prototyping
• Proven experience and proficiency using SolidWorks for mechanical design
• Strong working knowledge and understanding of GD&T and mechanical design standards
• Excellent communication skills, both written and oral

Benefits

• A fast-paced work environment
• Paid time off
• 401(k) retirement savings with a company match
• Clean, and well-lit production areas
• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs