Design Quality Engineer

About Us

Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first FDA‑cleared, portable, ultra‑low‑field, magnetic resonance brain imaging system capable of providing imaging at multiple points of care in a healthcare facility. Our mission is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging.

Job Title:

Design Quality Engineer

Location:

Guilford, CT, USA

The Design Quality Engineer requires collaboration and successful communication within a cross‑functional New Product Development (NPD) team to ensure products achieve performance, safety, and business objectives. The individual in this role will use comprehensive knowledge, leadership, and analytical skills to contribute to the development of new products and modification of existing products with the assurance of high quality to meet regulatory and quality requirements, and customer expectations.

This position will have a hands‑on role influencing Hyperfine’s emerging ideas, advanced technologies, and continually driving improvement of the design processes and products. The ideal candidate will have extensive experience and success in developing medical devices, as well as a working knowledge of patient‑specific applications.

• Document risk management activities for new and modified products.
• Review and contribute to process risk assessment and process validation.
• Interface with R&D, Regulatory Affairs, Clinical, Marketing, Product Management and Manufacturing functions in a project team environment.
• Develop inspection and sampling plans, test methods, and measurement systems (capability, MSA/gage R&R, etc.).
• Cross‑functionally develop, review, and approve Design History File documentation.
• Advise on development and implementation of quality assurance processes to ensure critical quality attributes are controlled and monitored, risk documentation, technical reports, and memos.
• Implement, maintain, and update procedures that ensure R&D documentation consistently meets Hyperfine’s product development process and design control requirements.
• Provide guidance on design control requirements to new product development and sustaining engineering teams.
• Support and own, when necessary, NC/CAPA or technical investigations.
• Work with engineering to ensure product requirements represent user needs and are objective, measurable, and verifiable.
• Work with product management, clinical, and engineering to ensure user needs are adequately documented, maintained, and validated.
• Quality representative in design reviews.
• Facilitate design transfer and ensure completion of all required quality documentation.
• Resolve technical issues as needed to maintain product quality.
• Estimate and gather necessary information on timelines and cost related to QA tasks.
• Review change notifications to ensure compliance to Quality System, QSR, and international requirements for new product development and sustaining engineering activities.
• All other duties as assigned.

• Proficient in Design Controls and compliance with FDA, cGMP, ISO, ASTM, and MDR requirements.
• Extensive knowledge of IEC 62304 and Agile software development processes.
• Advanced knowledge of scientific methods and applied statistics (hypothesis testing, determination of sample size, process capability).
• Expertise in analytical problem solving and DOE (Design of Experiments).
• Working knowledge of dimensioning and tolerancing, GD&T.
• Ability to drive design for manufacturing/service and inspection and usability/human factors engineering principles.
• Results‑oriented, cooperative, and pragmatic attitude.
• Effective communication (verbal, written, interpersonal) and conflict resolution skills.
• Solid basic math, problem solving, and deductive reasoning skills.
• Dynamic leadership skills; good interpersonal skills;
  Proven ability to work well as part of a team and independently with minimum supervision.
• Excellent relationship management skills, with the ability to work collaboratively with internal and external teams.
• Ability to work in a…