Project Engineer II — Medical Device Projects & Impact

Biomerics FMI LLC; Athens (TX); On-site; USD 70,000 - 90,000; Full time

Job summary

Biomerics FMI LLC in Texas is seeking a Project Engineer II to support cross-functional engineering and manufacturing projects for medical device development and production.

This role is ideal for individuals early in their careers who want to learn professional engineering concepts in a regulated, fast-paced environment.

Under supervision, you will follow established guidelines, build relationships with internal teams, and contribute to V&V and design reviews.

Qualifications

• Bachelor's degree in Mechanical, Biomedical, or related engineering field is required.
• Master's degree or MBA is a plus.
• 3–5 years of internship, co-op, or entry-level engineering experience preferred.
• Familiarity with FDA QSR and ISO 13485 requirements is preferred.
• Proficiency in CAD software (SolidWorks) and Microsoft Office Suite.

Responsibilities

• Contribute to project planning, scheduling, and execution.
• Coordinate with R&D, Quality, Manufacturing, and Supply Chain to support deliverables.
• Contribute to V&V activities, including test execution and data analysis for new products.
• Maintain and update technical documentation in compliance with FDA QSR, ISO 13485, and company procedures.
• Collect, organize, and analyze engineering data to support decisions.
• Participate in design reviews, risk assessments, and project meetings, providing input.
• Support the development, review, and implementation of engineering change orders (ECOs).
• Ensure all work adheres to procedures and quality/regulatory requirements.

Skills

Strong organizational skills

Effective written and verbal коммуника

Ability to work collaboratively

Education

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

Master's degree or MBA a plus

Tools

SolidWorks CAD

Microsoft Office Suite

Job description

Biomerics FMI LLC in Texas is seeking a Project Engineer II to support cross-functional engineering and manufacturing projects for medical device development and production.

This role is ideal for individuals early in their careers who want to learn professional engineering concepts in a regulated, fast-paced environment.

Under supervision, you will follow established guidelines, build relationships with internal teams, and contribute to V&V and design reviews.