Sr. Mechanical Engineer - Catheters

Cirtec Medical • Santa Clara, CA

76d • $100,000 - $150,000

About The Position

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 Mechanical Engineer who can bring innovation and creative thinking to the team. As a Senior Mechanical Engineer, you will lead product development teams to bring complex designs from concept to market. You will play a key role in the development of novel medical devices including state of the art minimally invasive catheter-based devices, delivery systems for implants, and other complex medical devices.

Requirements

• BS in Mechanical / Biomedical Engineering with minimum 5 years of experience within the Medical Device industry
• Experience designing and building catheters required
• Extensive knowledge and experience with product development of medical devices
• Strong understanding of mechanical component manufacturing (i.e. injection molding, extrusion, etc.)
• 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

Responsibilities

• Lead product development of complex mechanical and electromechanical 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

Benefits

• Training and career development
• Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid Time Off
• 401(k) retirement savings with a company match

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees