Laser Process Engineer

Biomerics•Brooklyn Park, MN

30d

About The Position

The Laser Process Engineer is responsible for developing, optimizing, and supporting laser-based manufacturing processes used in the production of medical devices. This role ensures processes meet quality, safety, and regulatory expectations while driving efficiency, scalability, and innovation across manufacturing operations.

Requirements

Bachelor’s degree in Engineering (Mechanical, Manufacturing, Biomedical, Materials, or related field).
2–5+ years of experience in laser processing within a regulated manufacturing environment; medical device experience strongly preferred.
Hands-on experience with laser systems (fiber, femtosecond, CO2, YAG, ultrafast, etc.).
Strong understanding of GD&T, materials science (metals & polymers), and precision micromachining.
Familiarity with FDA 21 CFR 820, ISO 13485, and ISO 14971.
Experience with DOE, statistical analysis, and process validation.
Excellent problem-solving, documentation, and cross-functional communication skills.
Experience with automation, vision systems, and laser programming.
Knowledge of fixture design and CAD software.
Six Sigma certification or equivalent statistical training.

Responsibilities

Develop, qualify, and optimize laser processes (e.g., laser cutting, welding, marking, drilling, ablation) for medical device components.
Identify, evaluate, and implement new laser technologies, tooling, and equipment to improve product quality and manufacturing capability.
Create and maintain process documentation, including work instructions, validation protocols (IQ/OQ/PQ), and technical reports in compliance with FDA and ISO 13485 requirements.
Lead root cause investigations and implement corrective and preventive actions (CAPA) for process-related issues.
Collaborate with R&D, Quality, and Manufacturing teams to support new product introductions and seamless transfer into production.
Analyze process data to monitor performance, improve yields, and reduce variability through statistical methods and DOE.
Support equipment maintenance, calibration, safety reviews, and continuous improvement initiatives.
Train production staff on laser equipment operation and process controls.