Laser Process Engineer

Description

Company Overview

Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next-generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets. 

At Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to the Biomerics values in all our interactions. It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here at Biomerics. We improve and advance the lives of our employees and patients who depend on our products.

At Biomerics, we believe in integrity, partnership, empowerment and accountability, trust, agility, teamwork, and excellence, and we care. Our team-oriented, customer-focused corporate culture prioritizes building strategic, mutually beneficial partnerships with customers and our team members.

Job Summary

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.

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.

Biomerics offers the following benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, Paid Holidays, and 401k.

Please, No Recruitment Agency calls or emails (we are not using recruitment services for this or any other role posted).

The salary estimates are estimates from this job board and not a guarantee of Biomerics’ salary range.

Biomerics does not accept non - solicited resumes or candidate submittals from search/recruiting agencies that are not already on Biomerics' approved agency list. Unsolicited resumes or candidate information submitted to Biomerics by search/recruiting agencies not already on Biomerics approved agency list shall become the property of Biomerics. If Biomerics subsequently hires the candidate, Biomerics shall not owe any fee to the submitting agency.

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.