Senior Mechanical Design Engineer (Catheter Development) - Cirtec Medical Corporation

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, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

JOB SUMMARY

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

ESSENTIAL RESPONSIBILITIES

• Lead product development of complex catheter based medical devices through various phases of concept feasibility, detailed design and verification
• Lead creation of product requirements and design specifications, and determine applicable regulatory standards and ensures appropriate integration into product requirements
• Generate and maintain computer-aided drawings (CAD) using SolidWorks, schematics and component specifications to document mechanical designs
• Drive 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
• Serve as the main technical contact with customers and communicate directly with customers to understand project / product needs, and present technical updates, risks and issues
• 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
• Lead and contribute towards creation of risk management documentation, including FMEAs
• Create engineering-level manufacturing process instructions, bill of materials and related manufacturing documentation
• Proactively anticipate technical risks and issues, and formulate and implement risk mitigations and corrective/preventive actions
• Assist program managers in developing and maintaining project plans, and in tracking program health in terms of schedule, budget, and technical risks and issues
• Collaborate with cross-functional team members to create and maintain Design History file per internal company procedures, FDA Design Control (21 CFR 820) and ISO 13485 requirements
• Mentor and provide guidance to other engineers and technicians
• Other duties as assigned

This is not a remote position.

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

• BS in Mechanical / Biomedical Engineering with minimum 5 years of experience within the Medical Device industry
• Must have a minimum of 3 years developing and designing catheters
• Extensive knowledge and experience with product development of catheter based medical devices
• Strong understanding of catheter manufacturing (i.e. braiding, extrusions, material selections, balloons, etc.)
• Hands on experience with catheter prototyping
• Proven experience and proficiency using SolidWorks for mechanical design
• Strong working knowledge and understanding of GD&T and mechanical design standards
• Excellent communication skills, both written and oral

WHAT WE OFFER

• A fast-paced work environment
• Paid time off
• 401(k) retirement savings with a company match
• 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

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 110,000 – 140,000 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.