Mechanical Design Engineer II (Catheter)

Department: NC2 - Engineering

Location: Santa Clara, CA

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This position is located on-site in Santa Clara, California

ABOUT THE COMPANY

More than just another design shop or contract manufacturer, Cirtec offers a uniquely comprehensive range of vertically integrated capabilities. Cirtec specializes in complex, difficult to produce components and devices in today-s most advanced product technologies including, neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist and interventional devices and delivery systems. We have the capabilities needed to bring products to full production, including assembly, packaging and testing, and in-house sterilization.

Our employees have the expertise needed to design innovative devices, solve complex design challenges, and help bring our customers- devices to market. If you are interested in working in a fun, challenging, fast-paced environment with a company that is growing and providing leading edge technology, Cirtec is the company for you!

YOU ARE A PART OF:

The engineering team consisting of other engineers with diverse backgrounds and expertise. The Engineering team works in close collaboration with Operations, R&D, and Purchasing. You will be involved in the design, development, documentation and validation of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, and design verification.

JOB SUMMARY

We are actively looking for a Mechanical Engineer II who can bring innovation and creative thinking to the team. As a Mechanical Engineer II, you will lead product development teams to bring complex catheter designs from concept to market. You will play a key role in the development of novel catheter based medical devices.

ESSENTIAL RESPONSIBILITIES

• Applies engineering knowledge and skills as technical engineer for all phases of development projects for complex catheter based 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

QUALIFICATIONS

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

• Must have a minimum of 2 years- experience within the Medical Device industry

• Experience in development of catheters is required

• Strong understanding of catheter design (i.e. braiding, extrusions, material selections, balloons, luer bonding, laminations, etc.)

• Hands on experience with catheter prototyping

• Experience in developing test protocols, test methods, executing engineering level tests, analyzing test data, and developing reports

• Experience in developing test fixtures

• 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

WHAT WE OFFER

• A fast-paced work environment

• 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

• Paid time off

• 401(k) retirement savings with a company match

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.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer

Cirtec Medical Corporation considers 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 of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

The pay range for this job is 100,000 - 125,000 per year. The successful candidate-s starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions. The expected base pay range for this role may be modified based on market conditions.

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