Project Engineer II

Biomerics FMI LLC • Athens, TX

2d

About The Position

The Project Engineer II supports cross-functional engineering and manufacturing projects for medical device development and production. This role is ideal for individuals beginning their careers who are eager to learn and apply professional engineering concepts while working in a regulated, fast-paced environment. The Project Engineer I works under general supervision, following established guidelines and procedures, and builds collaborative working relationships with internal teams.

Requirements

• Bachelor’s degree in Mechanical, Biomedical, or related engineering field.
• 3-5 years of relevant internship, co-op, or entry-level engineering experience preferred.
• Foundational understanding of engineering principles and standard problem-solving techniques.
• Familiarity with, or willingness to learn, FDA QSR and ISO 13485 requirements.
• Proficiency in CAD software (e.g., SolidWorks) and Microsoft Office Suite.
• Strong organizational skills, with the ability to manage time effectively and handle multiple priorities.
• Effective written and verbal communication skills.
• Ability to work collaboratively as part of a team, develop productive working relationships, and follow instructions and procedures.

Nice To Haves

• A Master's degree or MBA is a plus.

Responsibilities

• Contribute to project planning, scheduling, and execution by applying engineering knowledge to assigned tasks and deliverables.
• Coordinate and communicate with cross-functional teams, including R&D, Quality, Manufacturing, and Supply Chain, to support project deliverables.
• Contribute to verification and validation (V&V) activities, including test execution and data analysis, for new product introductions and sustaining projects.
• Maintain and update technical documentation (e.g., protocols, reports, drawings, specifications) in compliance with FDA Quality System Regulations (QSR), ISO 13485, and company procedures.
• Collect, organize, and analyze engineering data to support decision-making and identify opportunities for improvement.
• Participate in design reviews, risk assessments, and other project meetings, providing input within defined guidelines and seeking guidance when needed.
• Support the development, review, and implementation of engineering change orders (ECOs).
• Ensure all work is performed according to established procedures, quality standards, and regulatory requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level