Manufacturing Engineer II

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!

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

Requirements

• BS in Mechanical / Biomedical / Industrial Engineering or in an equivalent engineering discipline
• 2+ years of experience in medical device process development and/or manufacturing engineering
• Experience with new product introduction
• Solid knowledge of GMP and ISO 13485 regulations
• Must be able to review and interpret technical drawings and specifications
• 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

Nice-to-haves

• Experience with lean manufacturing techniques, value stream mapping, and continuous improvement methodologies
• Proficiency in Solidworks
• Experience working directly with catheters

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