Sr. Manufacturing Engineer

Description

Please note - Sponsorship or transfer of sponsorship, including OPT/F1 Visas, is not available for this role.

Novel Cath 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 outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly.

Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems. 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 challenges, you may be a perfect fit for our team!

This position is primarily responsible for maintaining, developing, and implementing robust 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 could implement creative ideas or solutions to improve assembly operations which may include development of tooling/fixturing as needed to accomplish this task.

• 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.
• 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.
• 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.
• Active participant in Material Review Board (MRB). 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.
• Participate in Kaizens and drive improvement efforts.
• Attends, schedules, and leads project meetings to evaluate current and future process initiatives.

• A Bachelor's degree in a STEM engineering required. Advanced degree preferred
• At least 5 years of experience required in manufacturing engineering required
• Experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred).
• Advanced knowledge of manufacturing and assembly processes.
• Previous experience with the ability to direct, lead and mentor engineers with respect to company engineering procedures, new product introduction, manufacturing support and tooling.
• Excellent verbal and written communication skills.
• Must be able to read, write and speak fluent English.
• Ability to lead, train, and engage manufacturing team members to reach Cirtec's quality standards.
• Must be able to read blueprints and interpret technical specifications and illustrations.
• The capacity to work well under pressure, change priorities on the fly, and take on new challenges.
• Project management skills and the ability to work to tight deadlines.
• Teamwork and people management skills.
• Experience associated with continuous improvement activities like participation in Kaizen events using lean manufacturing principles.
• A practical and logical approach to problem solving using lean six sigma concepts.
• Willingness to travel if required (