Mechanical Design Engineer ll

Department: LG Engineering

Location: Santa Clara, CA

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About us:

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!

Position Summary:

As a Mechanical Engineer II, you will work on product development teams to bring complex mechanical designs for implants, surgical devices and external electromechanical devices from concept to market.

Key Responsibilities:

• Applies engineering knowledge and skills as technical engineer for all phases of development projects.

• Generate and maintain computer-aided drawings (CAD) using Solidworks, schematics and component specifications to document mechanical designs.

• Participates in 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.

• 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.

• Creates medical device manufacturing process instructions, bill of materials, lot history travelers, and related documentation.

• Contributes towards coordinating and scheduling other staff to work on specific tasks.

• Communicates directly with clients to understand needs and present results.

• Effectively interfaces with and manages suppliers to fabricate prototype and final design components.

• Participates in product risk management and develops and implements risk mitigation strategies.

• Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position

Must Have:

• Bachelors in Mechanical / Biomedical Engineering, or an equivalent engineering discipline

• Minimum 2 - 5 years- experience within the Medical Device industry

• Experience in development of medical devices (i.e. delivery tools, catheters, consoles, surgical tools, etc.) is highly preferred

• Experience with CAD design using SolidWorks

• Excellent communication skills both written and oral

• Experience and working knowledge of medical device design control processes highly preferred

Physical Demands

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Working Environment

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

Cirtec Medical Corporation considers everyone for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all its related companies fully endorse equal opportunity. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec-s goal to create an enjoyable work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life. Our benefits include training and career development, healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.

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