Manufacturing Engineer II (NovelCath)

About us :

NovelCath a Cirtec company specializes in the design and development of complex, minimally invasive, interventional medical technologies. We have delivered first-of-a-kind medical devices for the Interventional Cardiology, Structural Heart, Electrophysiology and Neuromodulation markets.

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 :

This position is primarily responsible for maintaining, developing, and implementing cost-effective manufacturing processes and methods in accordance with customer product specifications for components and assemblies to Class III medical device quality standards. Manufacturing Engineers document processes and implement ideas or solutions to improve assembly operations which may include development of tooling / fixturing as needed to accomplish these tasks.

Key Responsibilities :

• Implement, plan, and execute continuous improvement projects for cost reduction, quality improvements and efficiency from conception to fully established production.
• Improve manufacturing process instructions, product flow, assembly methods, space allocation, product quality and safety performance.
• May help product development with the manufacturing launch of new products including evaluating yield targets, run rates, training needs and quality results.
• Prepare engineering change orders and coordinates the deployment of changes including training Operations team members.
• Perform product and process analysis for cost reduction, quality improvement and improved efficiency through scrap models and weekly project updates with required actions.
• Utilize tools associated with risk management (PFMEA / Hazard Analysis) to identify potential risks and the associated corrective actions.
• Support required equipment installation qualifications, process validations, and retroactive legacy qualifications or validations.
• Troubleshoot processes when defects occur. Help to determine root cause and implement effective containment and countermeasures.
• Help to lead Non-Conforming Material Report (NCMR) or customer complaint investigations.
• Develop, test, and provide ROI cost justification for various tools or equipment recommended for manufacturing.
• Disposition non-conforming products and develop re-work procedures.
• Communicate with customers regarding process improvements and requested production changes.
• Represent manufacturing on cross functional teams.
• Attends, schedules and may lead project meetings to evaluate current and future process initiatives.
• Arrange project meetings with customers to discuss current and future process improvements and development initiatives.

Must Have :

Salary Range : $77,000 - $95,000 depending upon qualifications and experience.

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 Cirtecs 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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