Design Quality Engineer

About the Role

The Design Quality Engineer is responsible for authoring Quality deliverables, reviewing, and maintaining the Design History File (DHF) and Risk File records, ensuring compliance with all applicable regulations. This position will collaborate with Development, Laboratory Operations, Regulatory Affairs, project/program management, and other cross-functional teams throughout product lifecycle activities supporting in vitro diagnostics (IVDs) and Laboratory Developed Tests (LDTs).

Key Responsibilities

• Support new product development, design changes, and post-launch activities as the Quality representative on sustaining projects.
• Create technical records, review, and approve the Design History File.
• Create and maintain Risk Management records in alignment with quality system and regulatory requirements, including design and use risk assessments.
• Perform risk assessment for Quality Events, Non-conformances, and complaints.
• Able to work independently with minimal supervision.
• Can plan and coordinate work according to the project schedule.
• Support inspection readiness by providing risk management / DHF documentation and creating quality plans as needed.
• Support design changes to assess and document the risk impact of product and process changes.

Requirements & Tech Stack

• Bachelor’s degree in a scientific, engineering, or related field.
• Working knowledge of product development processes.
• Understanding of ISO 13485 quality management system requirements.

Qualifications

• 0-4 years of experience in product development, IVD, diagnostics, biotech, or clinical laboratory environments.
• Design controls experience, including DHF, traceability matrices, V&V documentation, and design review records is a plus.
• Experience with medical device risk management (ISO 14971) is a plus.
• Working knowledge of ISO 15189 and ISO 22367 requirements is a plus.
• Ability to adapt to a fast-paced, dynamic work environment with shifting priorities is a plus.
• Experience supporting oncology diagnostic development, LDT workflows, or molecular assay development is a plus.

Physical Demands: Ability to lift routine office supplies and use standard office equipment. Ability to sit for extended periods of time. Majority of work performed in a desk or cubicle environment, with occasional exposure to laboratory environments.

Training: All job-specific, safety, and compliance training are assigned based on job functions.

Other: 10% travel may be required.