Sr. Laser Specialist

Description

About us:

NovelCath, a Cirtec company, specializes in the design and development of complex, minimally invasive, interventional medical technologies. We have delivered first-of-a-kind medical devices for the Interventional Cardiology, Structural Heart, Electrophysiology and Neuromodulation markets.

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 Sr. Laser Specialist 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; serving as the technical authority for laser-based manufacturing processes (cutting, welding, marking, drilling, micromachining). 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.

Technical Leadership

• Act as subject matter expert (SME) for all laser processing technologies and applications.
• Develop, optimize, and sustain robust laser manufacturing processes.
• Establish and control critical process parameters (CPPs) and critical quality attributes (CQAs).
• Lead root cause investigations related to laser processing defects and implement corrective actions.
• Define and maintain validated process windows and statistical capability targets.

• Author and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Support new product introduction (NPI) and manufacturing transfers.
• Develop process documentation including SOPs, work instructions, control plans, and validation reports.
• Ensure compliance with applicable regulatory and quality standards (e.g., FDA, ISO 13485, GMP as applicable).

• Specify, procure, install, and qualify laser systems and supporting equipment.
• Develop preventive and predictive maintenance strategies.
• Interface with equipment vendors for troubleshooting, upgrades, and performance improvements.
• Evaluate and implement emerging laser technologies to improve capability and scalability.

• Drive improvements in yield, cycle time, scrap reduction, and overall equipment effectiveness (OEE).
• Apply Lean Manufacturing, Six Sigma, and Design of Experiments (DOE) methodologies.
• Utilize statistical tools to monitor and improve process capability (Cp, Cpk).

Safety & Compliance

• Ensure compliance with laser safety standards (ANSI, OSHA).
• Conduct risk assessments (e.g., PFMEA) and implement mitigation strategies.
• Maintain documentation in accordance with company quality systems.

Must Have:

• 5-10+ years of experience with laser engineering and processing within a regulated environment.
• Demonstrated expertise in laser cutting, welding, or micromachining systems (fiber, CO2, UV, ultrafast lasers).
• Working experience with process validation (IQ/OQ/PQ) and regulatory compliance.
• Some college or additional certifications highly preferred.
• 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.
• Applying statistical analysis and problem solving skills 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.
• Aptitude in development and qualification of laser fixtures, tooling, and equipment.
• Possessing a high level of mechanical aptitude and problem-solving abilities.
• Ability to read, write and speak fluent English.
• Technical writing, reading, communication and organizational skills.
• Reporting preparation and good small group presentation abilities.
• Maintain high ethical standards.