Laser Engineer II

Cirtec Medical; Brooklyn Park (MN); On-site; USD 80,000 - 117,000; Full time

Benefits offered by this job

Training and career development

Healthcare and well-being programs

Paid Time Off

Job summary

Cirtec Medical is an established partner for complex medical devices, offering design, development, and turnkey manufacturing. The Laser Engineer will create laser processes for Class II/III devices, validate and document methods, and transfer processes to manufacturing.

Responsibilities include prototype builds, QA verifications, and training production staff to ensure successful product commercialization.

Qualifications

• Bachelor's degree in STEM engineering and 2+ years experience.
• Experience with laser applications and process development.
• Knowledge of FDA, cGMP, GDP; ISO 9001/13485.
• Proficiency with SolidWorks, CAD/CAM, CNC and G-code.

Responsibilities

• Design laser cutting/ablation/welding processes for medical devices.
• Create work instructions and production flow diagrams.
• Develop tooling and fixtures for laser processes.
• Support quoting and prototype activities.
• Train production engineers and operators.
• Ensure safety and compliance with standards.

Education

Bachelor's Degree (STEM Engineering discipline preferred)

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 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.


• Complies with company, quality, and safety standards, policies, and procedures.

This is not a remote position

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Must Have

• 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.


• 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.

Salary Range

80,000 - 117,000 / annual

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.

Benefits

• 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

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.