Biomerics · 1 month ago
Laser Process Engineer
Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. The Laser Process Engineer is responsible for developing, optimizing, and supporting laser-based manufacturing processes used in the production of medical devices, ensuring quality and regulatory compliance while driving efficiency and innovation.
BiotechnologyHealth CareLaserManufacturingMedical Device
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
Qualification
Required
Bachelor's degree in Engineering (Mechanical, Manufacturing, Biomedical, Materials, or related field)
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
Knowledge of fixture design and CAD software
Preferred
2–5+ years of experience in laser processing within a regulated manufacturing environment; medical device experience strongly preferred
Experience with automation, vision systems, and laser programming
Six Sigma certification or equivalent statistical training
Benefits
Medical/Dental/Vision Insurance
Short-Term Disability
Long-Term Disability
Life Insurance
Paid Vacation Days
Paid Holidays
401k
Company
Biomerics
Biomerics is a medical devices company providing polymer solutions.
H1B Sponsorship
Biomerics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (1)
2022 (1)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2023-05-17Series Unknown
2023-05-17Acquired
Recent News
Precedence Research
2025-11-07
2025-10-06
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