Design Assurance Quality Engineer

Company Overview

Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech indus-tries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next-genera-tion 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 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 the 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 Description

The Design Assurance Quality Engineer provides Quality Engineering support for new product development (NPD) projects from concept through design transfer and commercialization, while also supporting sustaining engineering activities for existing products throughout their lifecycle. This position partners with Design Engineering, Manufacturing Engineering, Operations, Supplier Quality, Business Development, and Quality to ensure customer, quality, and regulatory requirements are appropriately incorporated throughout product development and ongoing product support.

The Design Assurance Quality Engineer supports design controls, risk management, verification and validation, supplier and material qualification, design transfer, and product/process change activities in accordance with the Quality Management System (QMS) and applicable regulatory requirements. This position reports to the Site Quality Manager.

Responsibilities

• Execute design, development, and validation activities throughout the product life cycle in accordance with project scope.
• Utilize the Design Control process to create cost-effective and efficiently manufacturable products.
• Contribute to deliverables in compliance with MDR, ISO, and EN standards.
• Translate customer specifications and requirements into clear, concise performance and functional requirements.
• Conduct engineering evaluations, characterizations, design of experiments (DOE), bench testing, and other verification activities to improve and confirm design and process capabilities.
• Train and guide development technicians/operators in hands-on prototyping, testing, and process development.
• Execute document change requests and effectively train development/production operators and technicians on updated documentation.
• Design, procure, install, qualify, document, and train on new tooling/fixturing.
• Evaluate and implement new technologies and ideas for product improvement.
• Use statistical tools to analyze data and make development decisions to enhance process capability.
• Develop and refine manufacturing procedures and test/inspection plans to ensure quality requirements are met and manufacturing process risks are mitigated.