Hands-on Biomedical Device Project Engineer II

Biomerics; Athens (TX); On-site; USD 80,000 - 110,000; Full time

Job summary

Biomerics in the United States seeks a Project Engineer II to support cross-functional engineering and manufacturing projects for medical device development and production. This role suits individuals early in their careers who are eager to learn in a regulated, fast-paced environment.

Under general supervision, you will collaborate with R&D, Quality, Manufacturing, and Supply Chain to plan, execute, and document projects, contribute to V&V activities, and ensure compliance with FDA QSR and ISO

Qualifications

• Bachelor's degree in Mechanical or Biomedical engineering required; advanced degree a plus.
• Internship/Co-op/entry-level engineering experience preferred (3–5 years suggested).
• Familiarity with FDA QSR and ISO 13485 requirements.
• Proficiency in CAD and MS Office.
• Strong communication and teamwork skills.
• Ability to follow procedures and maintain documentation.

Responsibilities

• Contribute to project planning, scheduling, and execution.
• Coordinate with R&D, Quality, Manufacturing, and Supply Chain to support deliverables.
• Support verification and validation (V&V) activities, including test execution and data analysis.
• Maintain technical documentation in compliance with FDA QSR and ISO 13485.
• Collect, organize, and analyze engineering data to support decisions.
• Participate in design reviews, risk assessments, and ECO implementation.
• Ensure all work adheres to procedures and quality standards.

Skills

Strong organizational skills

Effective written & verbal comunicação

Team collaboration

Time management

Foundational engineering principles

Education

Bachelor's degree in Mechanical, Biomedical, or related engineering field

Master's degree or MBA is a plus

Tools

SolidWorks

Microsoft Office Suite

Job description

Biomerics in the United States seeks a Project Engineer II to support cross-functional engineering and manufacturing projects for medical device development and production. This role suits individuals early in their careers who are eager to learn in a regulated, fast-paced environment.

Under general supervision, you will collaborate with R&D, Quality, Manufacturing, and Supply Chain to plan, execute, and document projects, contribute to V&V activities, and ensure compliance with FDA QSR and ISO