Principal Mechanical Engineer

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 Principal Mechanical Engineer who can bring innovation and creative thinking to the team. As a Principal, you will work on 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.

ESSENTIAL 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 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 Creating test methods and corresponding test method validations Leading dFMEA creation Coordinating design verification activities Communicating technical risks as they arise
• Perform detailed design reviews and tolerance analyses to achieve product performance, cost, reliability, and manufacturability requirements.
• Communicates directly with clients to understand needs and present results.
• Effectively interface with and manage suppliers to fabricate prototype and final components.
• Manage workload to support various projects, in larger scale and complexity
• Mentorship of other engineers in various functions
• Maintain compliance to procedures and regulatory requirements
• Complete understanding of the product development process within the medical device industry
• Provides regular status updates to management and or customer
• Writes / updates work instructions, part specifications, verification protocols, and various technical documents
• 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.
• 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

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
• 10+ years’ experience within the Medical Device industry; or a combination of education and relevant work experience.
• Experience in development of medical devices (i.e. delivery tools, catheters, consoles, surgical tools, etc.) is highly preferred
• Experience in developing test protocols, test methods, executing engineering level tests, analyzing test data, and developing reports
• Experience in developing test fixtures
• Proficiency with Solidworks required
• 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 130,000 170,000 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.