Laser Engineer II

About the role

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 includes defining customer requirements, designing laser processes for manufacturability, validating and documenting processes, executing to established timelines, and committing to deliverables. The role also covers prototype and clinical builds, design verifications, process validations, and hands-on training of manufacturing methods to Production to ensure 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.

This is not a remote position.

Responsibilities

• Develop laser cutting, ablation, and welding 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.
• 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 (IQs, OQs, PQs, and design of experiments).
• Leverage design for manufacturability and lean methodologies to bolster process control, yield enhancements, scrap reduction, and quality improvements.
• As a collaborative member of a cross-functional program team, interface with customers, suppliers, and internal team members to ensure 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.
• Comply with company, quality, and safety standards, policies, and procedures.

Requirements

• 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.
• 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.
• 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.

Pay

Salary range: $80,000 – $117,000 per year.

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.