Project Engineer II

Company Overview Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next-generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets. At Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to the Biomerics values in all our interactions. It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here at Biomerics. We improve and advance the lives of our employees and patients who depend on our products. At Biomerics, we believe in integrity, partnership, empowerment and accountability, trust, agility, teamwork, and excellence, and we care. Our team-oriented, customer-focused corporate culture prioritizes building strategic, mutually beneficial partnerships with customers and our team members. Job Summary 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. Job 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. Requirements Education / Certifications Bachelor's degree in Mechanical, Biomedical, or related engineering field. A Master's degree or MBA is a plus. Job Requirements 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. #J-18808-Ljbffr Biomerics FMI LLC