Mechanical Design Engineer I

Cirtec-posted 7 months ago
$77,000 - $104,000/Yr
Full-time • Entry Level
Onsite • Santa Clara, CA
Publishing Industries
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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 Mechanical Design Engineer who can bring innovation and creative thinking to the team. As a Mechanical Design Engineer, you will be primarily responsible for defining, designing, and developing medical devices and related accessories. You will own efforts in developing solutions to product design, and design for manufacturability, translating requirements from the customer into realized products. You should be able to multitask and run multiple projects while meeting customer commitments.

  • 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.
  • 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.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Other duties as assigned.
  • Bachelor's degree in an Engineering discipline with 0-2 years of experience.
  • 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.
  • 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.
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