Sr. Design Quality Engineer

Avalign produces innovative, high-performance, and cost-effective medical devices with a focus on high growth and ingenuity. Our team is growing quickly, and our custom-made devices make a significant difference in the lives of medical professionals and their patients. Employees are actively involved in the design, engineering, and manufacture of technologically advanced medical devices to meet customer quality specifications.

About the role

The Design Quality Engineer will be responsible for quality and regulatory activities associated with new product development in both contract development and specification developer contexts. This role spans all aspects of the new product development process, including advising customers on incorporating Critical-To-Quality (CTQ) and Design-For-Inspection (DFI) into development. Internally, the engineer will ensure Avalign’s R&D activities comply with design control elements of the Quality Management System (QMS) and maintain regulatory-compliant technical documentation for assigned products. The role also involves assisting with regulatory filings, whether filed by Avalign, the customer, or a third party. A working knowledge of global design regulations (ISO 13485, ISO 14971, 21 CFR Part 820, and EU Medical Device Regulation) is required. The position reports directly to the Director of Regulatory Affairs.

Responsibilities

• Support a design control quality system compliant with ISO 13485, Medical Device Directives, and EU Medical Device Regulations (MDR).
• Review and approve activities associated with new product development, including user needs, design inputs/outputs, verification, validation, risk assessment, and design change activities.
• Participate in supply chain development, including supplier selection and qualification for new product development.
• Engage in design reviews as required by design control and development processes.
• Serve as a GD&T expert for contract developer and specification developer activities.
• Assist project managers with design transfer planning and execution, including advising on manufacturing process validations.
• Support Medical Device Reporting and Complaints processes for Avalign as specification developer products.
• Ensure design documentation is retained in design history files and technical files to support regulatory submissions and audits.
• Maintain regulatory filings for Avalign Technologies design-owned products, whether filed by Avalign, the customer, or a third party.
• Perform corporate internal audits as a lead or supporting auditor and participate in external audits.
• Conduct post-market surveillance for contract development and specification developer products.
• Update product design files following design changes and post-market surveillance activities.
• Write or update standard operating procedures, work instructions, or policies.
• Prepare responses to customer requests for information, such as product data or regulatory affairs statements.
• Assist in investigations of product complaints, root cause analysis, corrective action, trending, and reportability recommendations.
• Investigate and complete records related to assigned Nonconformances and CAPAs.
• Advise project teams on premarket regulatory requirements, export and labeling requirements, and other compliance issues.

Requirements

• Bachelor’s degree or equivalent experience in an engineering or scientific field.
• 5+ years of experience in a quality and/or engineering role.
• 2+ years of experience in the medical device industry (preferred).
• 2+ years of experience in quality within design control activities supporting new product development (preferred).
• Experience with ISO 13485, FDA 21 CFR 820, ISO 14971, MDR, or associated regulations.
• Ability to travel up to 25%.

Preferred Qualifications

• Expertise in project management and problem-solving, including identifying, investigating, and resolving technical/systemic issues.
• High attention to detail and persistence in resolving discrepancies.
• Excellent interpersonal, written, and verbal communication skills for all organizational levels, suppliers, and customers.
• Familiarity with Quality System Management software.
• Experience with regulatory submissions, including preparation or review for domestic or international projects.

Skills

• Self-directed and hands-on work style.
• Strong analytical abilities.
• Ability to influence and communicate effectively across functions and externally with customers.
• Strong verbal and written communication skills.

Benefits

• Competitive compensation and benefits package.
• Comprehensive medical, dental, and vision insurance.
• Paid vacation and 10 observed paid holidays per year.
• Employer-funded Basic Life and AD&D insurance.
• Employer-funded Short-Term and Long-Term Disability insurance.
• Tuition reimbursement.
• 401(k) with company match.
• Generous employee referral bonus program.
• Additional resources such as travel assistance and Employee Assistance Program (EAP).