Design Assurance Quality Engineer

Biomerics LLC•Salt Lake City, UT

16h

About The Position

The Design Assurance Quality Engineer provides Quality Engineering support for new product development projects from concept through design transfer and commercialization, and supports sustaining engineering activities for existing products throughout their lifecycle. The role partners with Design Engineering, Manufacturing Engineering, Operations, Supplier Quality, Business Development, and Quality to ensure customer, quality, and regulatory requirements are incorporated into product development and ongoing product support. The position supports design controls, risk management, verification and validation, supplier and material qualification, design transfer, and product and process changes in accordance with the Quality Management System and applicable regulatory requirements. It reports to the Site Quality Manager and supports activities for the BBPK and BSLC sites, with travel up to 30% to the Brooklyn Park, Minnesota location.

Requirements

Bachelor’s degree or technical degree in Engineering or a related technical field; equivalent education and experience may be considered.
At least 5 years of experience in medical device manufacturing, product development, Quality Engineering, or a related regulated environment.
Working knowledge of applicable FDA Quality System requirements, ISO 13485, and ISO 14971.
Experience with medical device design controls and new product development processes.
Experience with product and process verification and validation activities, including protocol development and execution.
Experience with DFMEAs, PFMEAs, and Risk Management activities.
Understanding of design transfer, manufacturing processes, production readiness, and sustaining engineering activities.
Strong project management and organizational skills, with demonstrated initiative in taking ownership of and completing assigned projects.
Strong verbal and written communication skills, including the ability to document technical and quality activities effectively.
Ability to work effectively within cross-functional project teams.
Ability to manage and prioritize multiple projects, objectives, and deadlines in a fast-paced environment.
Strong analytical and problem-solving skills with attention to detail.
Ability to travel up to 30% to support the Brooklyn Park, Minnesota location.

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 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 documented and addressed.
Collaborate with Design Engineers and Technicians on developing, reviewing, executing, and documenting 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 developing and maintaining DFMEAs, PFMEAs, and product Risk Management documentation.
Collaborate with Supplier Quality to qualify new suppliers and ensure new components, raw materials, and purchased products meet applicable specifications and quality requirements.
Support qualification and validation of new materials, components, manufacturing processes, equipment, and test methods as required.
Author, assist with, and approve where applicable inspection methods, acceptance criteria, test methods, and inspection equipment to support new product introduction.
Work 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 for changes to existing products, processes, equipment, materials, or suppliers.
Support investigation and resolution of manufacturing product and process issues, including nonconformances, deviations, and recurring quality issues.
Support CAPA and root-cause investigations related to product design, manufacturing processes, and product performance as needed.
Partner with Manufacturing Engineering, Operations, and Quality to identify and implement improvements to existing products and manufacturing processes.
Review and update DFMEAs, PFMEAs, risk management documentation, specifications, drawings, inspection requirements, and other technical documentation resulting from sustaining engineering activities.
Provide Quality Engineering support for cost reduction, process improvement, supplier changes, and product lifecycle initiatives while maintaining product quality and regulatory compliance.
Support transfer and implementation of engineering changes into production, ensuring changes are documented, validated, and communicated.
Provide technical and quality support for customer complaints or field issues when investigation requires design or engineering expertise.
Ensure assigned new product development and sustaining activities comply with the company’s QMS, applicable regulatory requirements, and customer expectations.
Identify opportunities to improve design assurance, new product development, and sustaining engineering processes.
Perform other assignments and responsibilities as requested.