Design Assurance Quality Engineer

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 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 ensuring product quality and regulatory compliance are maintained.
• Support the transfer and implementation of engineering changes into production, ensuring changes are appropriately documented, validated, and communicated.
• Provide technical and quality support for customer complaints or field issues when investigation requires design or engineering expertise.
• Ensure assigned NPD and sustaining activities are completed in accordance 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.

Requirements

• Bachelor’s degree or technical degree in Engineering or a related technical field; equivalent education and experience may be considered.
• Minimum of 5 years of experience in a medical device manufacturing, product development, Quality Engineering, or 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 effectively document technical and quality activities.
• 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.
• Travel up to 30% to support Brooklyn Park, MN location.

Biomerics offers the following benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, Paid Holidays, and 401k.

Please, No Recruitment Agency calls or emails (we are not using recruitment services for this or any other role posted).

The salary estimates are estimates from this job board and not a guarantee of Biomerics’ salary range.