Design Assurance Quality Engineer

Socket.dev; Brooklyn Park (MN); On-site; USD 85,000 - 120,000; Full time

Job summary

Biomerics in Minnesota is seeking a Design Assurance Quality Engineer to drive quality engineering for new product development and sustaining activities. You will partner with Design Engineering, Manufacturing, Operations, Supplier Quality, and Quality to ensure regulatory requirements are incorporated from concept through design transfer.

The role focuses on design controls, risk management, verification/validation, and change management, with responsibility to train teams, support CFR 21 Part

Qualifications

• Bachelor’s degree or technical degree in Engineering or related field.
• Minimum 5 years in a medical device manufacturing or regulated environment.
• Experience with FDA QMS requirements, ISO 13485, ISO 14971.
• Experience with design controls and new product development processes.
• Experience with verification and validation activities, including protocols.
• Experience with DFMEAs and PFMEAs.

Responsibilities

• Execute design, development, and validation activities throughout the product life cycle.
• Utilize the Design Control process to create manufacturable products.
• Contribute to deliverables in compliance with MDR, ISO 13485, and EN standards.
• Translate customer requirements into performance and functional requirements.
• Conduct evaluations, DOE, bench testing, and other verification activities.
• Train development and production personnel on updated documentation.
• Support design transfer, tooling, and process validation activities.
• Analyze data with statistical tools to guide decisions.
• Develop and refine manufacturing procedures and test plans.

Skills

Quality Engineering

Project management

Regulatory compliance

Process improvement

Data analysis

Education

Bachelor’s degree in Engineering or related field

Tools

DFMEA

PFMEA

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

• 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.

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.

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.