Project Engineer Jobs

About The Position

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.