Sr. Design Quality Engineer

Hyperfine (NASDAQ: HYPR) is the groundbreaking MedTech company that created Swoop, the world's first FDA-cleared portable magnetic resonance imaging (MRI) system capable of providing neuroimaging at the point of care. Our mission is to transform patient care by creating access to life-saving diagnostics and actionable data at the point of care.

The Sr. Design Quality Engineer requires collaboration and successful communication within a cross-functional New Product Development (NPD) team to ensure product performance, safety, compliance, and to achieve business objectives. This position will have a hands-on role influencing Hyperfine's emerging ideas, advanced technologies, and unique processes.

Key Responsibilities:

• Lead risk management activities for new and modified products
• Develop inspection and sampling plans, test methods, and measurement systems
• Review and approve design control, quality, manufacturing, engineering, validation, and other technical documentation
• Lead development and implementation of quality assurance processes
• Create quality system documentation
• Partner with engineering to ensure product requirements represent user needs
• Facilitate design transfer and ensure completion of all required quality documentation
• Review and contribute to process risk assessment and process validation

Required Qualifications:

• BS in Engineering (ME, BME preferred) or related technical field
• 6+ years of related work experience in Engineering or Quality role
• 3+ years of experience in team-based medical device product development
• Expert in Design Controls and compliance to FDA, cGMP, ISO, ASTM, MDD, and MDR requirements
• Advanced knowledge of scientific methods and applied statistics
• Experience with patient-specific multi-use devices

Preferred Qualifications:

• MS in Science
• ASQ, CQE or CSSBB certification
• Experience with Magnetic Resonance Imaging (MRI) and procedures

This role offers an exciting opportunity to work on cutting-edge medical imaging technology and make a significant impact on patient care worldwide. Join Hyperfine and be part of a team transforming the accessibility of MRI technology.