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

JOB SUMMARY

We are actively looking for a Manufacturing Engineer II who can bring innovation and creative thinking to the team on catheter based devices. As a Manufacturing Engineer II, you will be primarily responsible for maintaining, developing, and implementing cost-effective manufacturing processes and methods. You will provide day to day support of the catheter manufacturing floor operations from an engineering perspective. Manufacturing Engineers document processes, implement ideas and solutions to improve assembly operations and reduce costs, develop tooling/fixturing, drive investigations tied to non-conformances. Experience with validations, risk management, and Lean Principles is preferred.

ESSENTIAL RESPONSIBILITIES

• Develops and implements robust cost-effective manufacturing processes, and improves product flow and product quality and safety performance for both sustained and new products

• Leads design transfer of new products to production including establishing assembly time and yield targets, training needs and quality control

• Develops, tests and implements tools, fixtures and equipment required for manufacturing processes

• Develops manufacturing process instructions, inspection plans and lot history travelers

• Leads creation of manufacturing process validation plans, validation protocols and reports, and implements manufacturing process validations and test method validations

• Collaborates with cross-functional teams during development phase(s), and provides inputs and recommendations for design for manufacturability (DFM)

• Develops and maintains process risk documentation (e.g. PFMEA) to identify potential risks, and implement preventive and corrective actions

• Manages and/or supports production and test equipment maintenance, qualification and calibration

• Performs analysis for cost reduction, and quality and efficiency improvement

• Prepares engineering change orders and coordinates the implementation of changes including training production staff

• Troubleshoots designs and processes when defects occur, leads investigation to determine root cause and implements effective containment and counter measures

• Dispositions non-conforming products and develops required re-work procedures

• Communicates with customers regarding process improvements and production changes

• Perform other responsibilities 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 / Industrial Engineering or in an equivalent engineering discipline

• 2+ years of experience in catheter based medical device process development and/or manufacturing engineering

• Experience with lean manufacturing techniques, value stream mapping, and continuous improvement methodologies preferred

• Experience with new product introduction

• Solid knowledge of GMP and ISO 13485 regulations

• Must be able to review and interpret technical drawings and specifications. Proficiency in Solidworks preferred.

• Strong computer skills, including the MS Office suite

• Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral

• Must have demonstrated organizational skills to manage multiple priorities and schedules

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 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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