Manufacturing Engineer

About us:
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

Position Summary:
This position is primarily responsible for developing and implementing robust cost-effective manufacturing processes and methods in accordance with product specifications and Class III medical device quality standards. This position recommends and implements improvements to sustained production processes, methods and controls; as well as coordinates the launch of new products into pilot production.

Key Responsibilities:

• Improves manufacturing processes, methods and controls for cost reduction, quality improvements and efficiency for both sustained and new products.
• Prepares engineering change orders and coordinates the deployment of changes including training operation team members.
• Improve manufacturing process instructions, product flow, assembly methods, space allocation, product quality and safety performance for both sustained and new products.
• Coordinates the manufacturing launch of new products including establishing yield targets, run rates, training needs, and evaluating results.
• Develop and qualify various tools and equipment required for manufacturing processes.
• Performs product and process analysis for cost reduction, quality improvement and improved efficiency.
• Utilizing tools associated with risk management (e.g., PFMEA) to identify potential risks and the associated corrective actions.
• Supporting required equipment qualification and process validations (IQ, OQ and PQ).
• Troubleshoot manufacturing processes when defects occur. Determine root cause and implement effective containment and countermeasures.
• Disposition non-conforming products and develop re-work procedures.
• Communicate with customers regarding process improvements and production changes.
• Represent manufacturing on cross functional teams.
• Participate in Kaizen events and drive continuous improvement efforts.
• Attends and schedules project meetings to determine current and future process initiatives.
• Complies with company, quality and safety standards, policies, and procedures
• Other duties as assigned.

This is not a remote position.

Must Have:

• Bachelor's degree in an engineering discipline.
• +1 Year experience in similar positions.
• Prefer 1+ years of experience with Class II or III Medical devices, FDA standards, ISO 13485 and GMP principles.
• Knowledge of manufacturing and assembly processes.
• Association with supporting documents including, ECN's, process deviation, non-conformances, stop shipment notifications and all associated quality related documents.
• Experience associated with continuous improvement activities, including participations and/or facilitating Kaizen events using lean manufacturing principles.
• The ability to understand a range of engineering functions and procedures.
• Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office.
• Must possess excellent verbal communication, organizational and management skills.
• The capacity to work well under pressure and take on new challenges.
• Organizational and time management skills.
• Project management skills and the ability to work to tight deadlines.
• High level of English.
• Passport and Visa are desirable.

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.

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 Cirtec's goal to create a great work environment and to keep the company a great place to work.