Sr. Laser Engineer

Cirtec Medical; Brooklyn Park (MN); On-site; USD 100,000 - 140,000; Full time

Job summary

Cirtec Medical in Minnesota is seeking a Sr. Laser Engineer to design, develop, and qualify laser manufacturing processes for Class II/III devices. You will translate customer requirements into manufacturable processes, validate them, and document results to meet timelines and deliverables.

You will lead prototype builds, design verifications, and process validations, and train Production staff to ensure successful transfer to manufacturing, with emphasis on tooling and poka‑yoke approaches.

Qualifications

• Must have a Bachelor's degree in a STEM Engineering discipline.
• 5+ years of experience in Laser Engineering.
• Experience in an engineering environment with mechanical, tooling and manufacturing processes (medical device preferred).
• Experience with laser applications such as laser welding, ablation, and machining with a focus on process development.
• Ability to apply statistical analysis when determining process capabilities.
• Comfortable working on cross-functional project teams.
• Proficiency with SolidWorks, CAD/CAM, CNC, G-code programming.
• Familiar with FDA, cGMP, GDP and ISO 9001/ISO 13485.
• Aptitude in development and qualification of laser fixtures, tooling, and equipment.
• Strong mechanical aptitude and problem-solving abilities.
• Must be able to read, write and speak fluent English.
• Technical writing, reading, communication and organizational skills.

Responsibilities

• Develop laser cutting, ablation and welding processes for medical device components and assemblies.
• Create work instructions, inspection plans, and production flow diagrams.
• Develop methodologies to reduce costs, processing time, and improve quality in laser processing.
• Support quoting and prototype activities with Business Development and Applications Engineering.
• Characterize and validate laser processes using statistical tools (IQs, OQs, PQs) and DOE.
• Leverage DFM and lean methodologies to improve process control and yield.
• Collaborate with customers, suppliers, and internal teams to meet contract requirements, timelines, and budgets.
• Train production engineers, technicians, and operators on laser operations for program transfer.
• Maintain laser safety and promote a safe team environment.
• Recommend capital equipment for yearly budget.

Skills

Laser engineering

Statistical analysis

Cross-functional teamwork

English fluency

Technical writing

Mechanical aptitude

Education

Bachelor's degree in STEM Engineering

Tools

SolidWorks

CAD/CAM

CNC

G-code programming

Job description

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 Sr. 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. 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 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.
• 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, 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.
• 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 in a STEM Engineering discipline
• 5+ years of experience in Laser Engineering
• 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.
• 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.
• Maintain high ethical standards.

Salary Range: $100,000 to 140,000 based on skills and experience

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. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

• Training and career development, Healthcare and well‑being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.