Cirtec Medical · 9 hours ago
Mechanical Engineer II (Catheters)
Santa Clara, CA
Full-time
Onsite
Entry, Mid Level
$88K/yr - $115K/yr
2+ years expCirtec Medical is a leading outsourcing partner for complex medical devices, specializing in Class II and III devices. They are seeking a Mechanical Engineer II to define, design, and develop catheter-based medical devices, ensuring compliance with regulatory requirements and managing multiple projects.
Responsibilities
Owns the design and development of medical devices through:
Transformation of internal and external inputs into outputs
Developing design requirements and specifications with mechanical and electrical components and assemblies
Creating test methods and corresponding test method validations
Coordinating design verification activities
Generating 3D models and engineering drawings utilizing Solidworks
Performing tolerance analyses to ensure component interactions are understood
Understanding the functional performance of the products as they are developed
Communicating technical risks as they arise
Host design reviews with internal and external stakeholders
Manage workload to support various projects, in smaller scale and complexity
Proven to work independently on most tasks given
Maintain compliance to procedures and regulatory requirements
Provides regular status updates to management and or customer
Writes/updates work instructions, part specifications, verification protocols, and various technical documents
Reliable, consistent, and punctual attendance is an essential function of the job
Qualification
Required
A Bachelor's degree (STEM engineering discipline preferred) and 2 years of experience required; or a combination of education and relevant work experience
Experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred)
FDA, cGMP, GDP principles and practices, (ISO 9001, ISO 13485)
Proficiency with Solidworks required
Knowledge of dimensioning and tolerances, GD&T
Computer skills associated with Microsoft software
Must be able to read, write and speak fluent English
Excellent reading, writing, communication, and organizational skills
Maintains performance with changing priorities under supervision
Possess team collaboration skills
Strong mechanical aptitude
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
Company
Cirtec Medical
Whether you’re a cutting-edge startup or a leading Class II or III medical device manufacturer, Cirtec is here to help bring life-enhancing therapies to market – quickly and cost-effectively.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Brian Highley
CEO
John Kraus
Chief Operations Officer
Recent News
2025-10-02
2025-09-17
2025-08-29
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