Project Engineer II

Biomerics•Athens, TX

About The Position

The Project Engineer II supports cross-functional engineering and manufacturing projects for medical device development and production. The role is intended for individuals beginning their careers who are eager to learn and apply professional engineering concepts in a regulated, fast-paced environment. The position works under general supervision, follows established guidelines and procedures, and builds collaborative working relationships with internal teams. Biomerics is a vertically integrated manufacturer and provider of polymer solutions for the medical device and biotech industries. The company designs, develops, and produces devices for diagnostic and interventional procedures, including vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets. Its culture emphasizes integrity, partnership, empowerment and accountability, trust, agility, teamwork, excellence, and care.

Requirements

  • Bachelor’s degree in Mechanical, Biomedical, or a related engineering field.
  • Three to five 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 such as SolidWorks and the Microsoft Office Suite.
  • Strong organizational skills, effective time management, and ability to handle multiple priorities.
  • Effective written and verbal communication skills.
  • Ability to work collaboratively, develop productive working relationships, and follow instructions and procedures.

Nice To Haves

  • A Master's degree or MBA is a plus.
  • Three to five years of relevant internship, co-op, or entry-level engineering experience is preferred.

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, including protocols, reports, drawings, and 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 work is performed according to established procedures, quality standards, and regulatory requirements.
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