Sr. Laser Engineer - Process Development

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:

The Senior Laser Engineer, Process Development is primarily responsible for designing, developing, and qualifying laser manufacturing processes, employing multiple engineering disciplines, for the manufacture of Class II and Class III medical devices. This involves defining customer requirements, designing laser processes for manufacturability, validating, and documenting processes, executing to established timelines, and committing to deliverables.

This position is also responsible for prototype and clinical builds, design verifications, process validations, and providing hands-on training of manufacturing methods to Production, to assure successful product commercialization and transfer to manufacturing. Critical to successful laser process development are the design and implementation of effective manufacturing tooling and fixtures, ergonomic workplace considerations, and application of poka-yoke opportunities aimed at mistake-proofing processes.

Key Responsibilities:

• Develop laser welding and ablation processes; create, establish, and implement methods, operation sequences, and processes for the manufacture of medical device components, assemblies, subassemblies, and final assemblies.
• Formalize manufacturing processes and inspection methods through the creation of work instructions, inspection plans, and production flow diagrams.
• Characterize, develop, and validate laser processes using statistical tools, i.e., IQ’s, OQ’s, PQ’s and design of experiments.
• Leverage design for manufacturability and lean methodologies that bolster process control, yield enhancements, scrap reduction, and quality improvements.
• Assist Business Development and Applications Engineering in quoting and proposal development and support quick turn/prototype activities.
• As a collaborative member of a cross-functional program team, interface with customers, suppliers, and internal team members to assure projects meet contract requirements, are completed on time, and are within budget.
• Train Production engineers, technicians, and operators on pertinent laser operation to ensure successful program transfer into manufacturing.
• Maintain and promote laser and team safety.
• Research and recommend capital equipment for the yearly budget.

Must Have:

• A Bachelor’s Degree (STEM Engineering discipline preferred) and 5 years of experience required; or a combination of education and relevant work experience.
• Minimum of 2 years developing programs for laser welding
• Experience in an engineering environment with mechanical, tool design, and manufacturing processes
• Experience with laser applications, such as laser welding, ablation, and machining, with a focus on process development.
• Apply statistical analysis when determining process capabilities.
• Comfortable and productive functioning on cross-functional project teams.
• Proficiency with SolidWorks, CAD/CAM, CNC, G-code programming.
• Familiar with FDA, cGMP, GDP principles and practices, and ISO 9001/ISO 13485.
• Aptitude in development and qualification of laser fixtures, tooling, and equipment.
• Possess a high level of mechanical aptitude and problem-solving abilities.
• Must be able to read, write and speak fluent English.
• Technical writing, reading, communication and organizational skills.

Good to have:

• Medical device experience
• Hermetic IPG welding experience a plus.

Salary Range: 95000 to 120000

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 ind