Sr. Design Quality Engineer - Franklin Lakes, NJ

Company Profile

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.

Today, eighty percent of the world's population lacks access to MRI. Hyperfine is on a mission to address the limitations of current imaging technologies and make MR imaging accessible anytime and anywhere.

Do you have a background in magnetic resonance imaging, deep learning, electrical engineering, physics, or related fields? What about health equipment sales, business development, or marketing? Hyperfine lives and works on the cutting edge of medical imaging accessibility. If you enjoy a challenge as much as you value a committed workplace, we could be the next step in your rising career.

Location: Guilford, CT

Relocation: Available

SUMMARY:

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. The Sr. Design Quality Engineer uses 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 unique processes. The ideal candidate will have extensive experience and success in developing medical devices, as well as a working knowledge of patient-specific applications and additive manufacturing technologies.

RESPONSIBILITIES:

• Lead risk management activities for new and modified products.

• Develop inspection and sampling plans, test methods, and measurement systems (capability, MSA/gage R&R, etc.).

• Review and approve design control, quality, manufacturing, engineering, validation, and other technical documentation.

• Lead development and implementation of quality assurance processes to ensure critical quality attributes are controlled and monitored.

• Create quality system documentation (procedures, work instructions, FMEAs and RMRs, technical reports, records, memos, and essential requirements).

• Partner effectively with engineering to ensure product requirements represent user needs and are objective, measurable, and verifiable.

• Quality representative in design reviews.

• Facilitate design transfer and ensure completion of all required quality documentation.

• Review and contribute to process risk assessment and process validation.

• Resolve technical issues as needed to maintain product quality; owning or a participating team member for NC/CAPAs as required.

• 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 NPD and Sustaining activities.

• All other duties as assigned.

KNOWLEDGE AND SKILL:

• Expert in Design Controls and compliance to FDA, cGMP, ISO, ASTM, MDD, and MDR requirements.

• 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 and inspection as well as usability/human factors engineering principles.

• Solution-oriented, cooperative, and pragmatic attitude.

• Effective communication (verbal, written, interpersonal) and conflict resolution skills.

• Experience with patient-specific multi-use devices required.

• Experience with Magnetic Resonance Imaging (MRI) and procedures preferred.

• Solid basic math, problem solving, and deductive reasoning skills.

• Dynamic leadership skills; good interpersonal skills; ability to work effectively in a team environment and build strong working relationships, as well as ability to work independently.

• Ability to work in a fast-paced environment; ability to work well under pressure and maintain a positive, enthusiastic, and problem-solving attitude.

• Computer literate in various software applications (i.e. - Word, Outlook, Visio, Excel, Access, Minitab).

• Independent organization and prioritization of multiple tasks.

EDUCATION/EXPERIENCE REQUIRED:

• BS in Engineering (ME, BME preferred) or related technical field. Experience in lieu of education will be considered.

• 6+ years of related work experience in Engineering or Quality role.

• 3+ years of experience in team-based medical device product development.

• Experience working through all aspects of medical device design, including voice of customer/user needs, design requirements, verification and validation, process validation, and design transfer to manufacturing.

• MS in Science preferred.

• ASQ, CQE or CSSBB preferred.

PHYSICAL DEMANDS:

• This role is based in Hyperfine's facility in Guilford, CT

• Able to frequently lift up to 25lb and occasionally up to 50lb.

• Able to properly wear PPE (Personal Protective Equipment) required for the area of operation such as gloves, ear protection, eye protection, smocks, etc.