Design Assurance Quality Engineer

Biomerics LLC; Salt Lake City (UT); On-site; USD 95,000 - 120,000; Full time

Job summary

Biomerics LLC in Salt Lake City, UT, seeks a Design Assurance Quality Engineer to drive quality engineering across NPD and sustaining activities for medical devices.

You will partner with Design Engineering, Manufacturing, Operations, and Supplier Quality to ensure design controls, risk management, verification, validation, and regulatory requirements are incorporated from concept through transfer and commercialization.

Qualifications

• Experience supporting NPD, design transfer, and sustaining activities for medical devices.
• Strong knowledge of design controls, risk management, verification and validation.
• Proficiency with regulatory requirements (FDA, ISO 13485) and CAPA processes.

Responsibilities

• Provide Quality Engineering support across the product lifecycle from concept to production.
• Maintain DHF and Engineering Project File documentation.
• Collaborate with cross-functional teams to ensure regulatory and quality requirements are met.

Skills

Quality engineering

Design assurance

Risk management

Design controls

Verification and validation

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in engineering

Tools

QMS software

Documentation systems

Job description

Description

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

• Provide Quality Engineering and Design Assurance support throughout the new product development lifecycle, from concept and prototyping through design transfer and production for BBPK and BSLC sites.
• Manage and support quality deliverables associated with the design process, including Design History File (DHF) and Engineering Project File documentation.
• Participate as the Quality representative on cross-functional design and development teams to ensure customer requirements, product specifications, quality requirements, and applicable regulatory requirements are appropriately documented and addressed.
• Collaborate with Design Engineers and Technicians in the development, review, execution, and documentation of verification and validation protocols and reports.
• Support design control activities, including review of design inputs, design outputs, design reviews, verification, validation, and design transfer documentation.
• Participate in the development and maintenance of DFMEAs, PFMEAs, and product Risk Management documentation, ensuring risks are appropriately identified, evaluated, mitigated, and documented.
• Collaborate with Supplier Quality to ensure new suppliers are appropriately qualified and new components, raw materials, and purchased products meet applicable specifications and quality requirements.
• Support the qualification and validation of new materials, components, manufacturing processes, equipment, and test methods as required.
• Author, assist, and approve where applicable the development and validation of inspection methods, acceptance criteria, test methods, and inspection equipment to support new product introduction.
• Work closely with Manufacturing Engineering, Operations, Business Development, Design Engineering, and Quality during concept development, prototyping, process development, and transfer of new products into production.
• Ensure design specifications and critical product requirements are accurately translated into manufacturing and process specifications during design transfer.
• Provide Quality Engineering support for sustaining engineering activities for existing commercial products, including product, process, material, equipment, and supplier changes.
• Evaluate proposed engineering changes for potential impact to product quality, design controls, risk management, regulatory requirements, and existing verification and validation.
• Determine and support appropriate verification and validation activities associated with changes to existing products, processes, equipment, materials, or suppliers.
• Support investigation and resolution of product and process issues identified during manufacturing, including nonconformances, deviations, and recurring quality issues.
• Support CAPA and root-cause investigations related to pr