Sr. Manufacturing Engineer

About the position

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! 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.

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.
• 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.

Requirements

• A Bachelors degree (STEM engineering discipline preferred) and 5 years of experience required.
• Experience in an engineering environment with mechanical, tool design, and manufacturing processes.
• Must be able to read blueprints and interpret technical specifications and illustrations.

Nice-to-haves

• Previous experience with Class III Medical devices, FDA standards, ISO 13485 and GMP principles preferred.

Benefits

• Training and career development
• Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid Time Off
• 401(k) retirement savings with a company match