Laser Engineer II

Description

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 Laser Engineer 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.

Key Responsibilities

• Develop laser cutting, ablation and welding processes; and create, establish, and implement methods, operation sequences, and processes for the manufacture of medical device components, assemblies, subassemblies, and final assemblies.
• Create advanced methodologies and schemes to laser processing, aimed at cost reduction, decreased processing time, and improved quality.
• Assist Business Development and Applications Engineering in quoting and proposal development and support quick turn/prototype activities.
• 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.
• 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.

Critical to Successful Laser Process Development

• Design and implementation of effective manufacturing tooling and fixtures.
• Ergonomic workplace considerations.
• Application of poka-yoke opportunities aimed at mistake-proofing processes.

Qualifications

• A Bachelor’s Degree (STEM Engineering discipline preferred) and 2 years of experience required; or a combination of education and relevant work experience.
• Experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred).
• Experience with laser applications, such as laser welding, ablation, and machining, with a focus on process development.
• Experience with applying statistical analysis when determining process capabilities.
• Comfortable and productive functioning on cross-functional project teams.
• Proficiency with SolidWorks, CAD/CAM, CNC, G-code programming.
• Familiarity with FDA, cGMP, GDP principles and practices, and ISO 9001/ISO 13485.
• 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.
• Report preparation and good small group presentation abilities.

Benefits

Cirtec Medical Corporation provides a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include:

• 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

Pay

Salary Range: $80,000 - $117,000 / annual