Staff Systems Architect

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.

Job Title: Staff Systems Architect

Location: Guilford, CT (Onsite)

Summary:

The Staff Systems Architect is responsible for understanding the impact of, managing, and integrating a wide range of engineering activities in a complex medical device (Swoop System). Communication, attention to detail, organization, and technical knowledge across a broad set of engineering disciplines are key attributes of the preferred candidate.

Responsibilities:

Design Controls

• Medical device design controls and design control content
• Continuously improve design controls processes where possible
• Write Design Inputs in collaboration with appropriately identified stakeholders
• Analyze the impact of all changes on the medical devices
• Maintain requirements traceability

MR Safety

• Serve as subject matter expert within Hyperfine for MR safety, including working with field teams
• Expanding the list of compatible devices within critical care settings.
• Risk analyses and actively identify areas for risk reductions

General

• Manage multiple tasks to ensure timely fulfillment of project objectives and deliverables
• Communicate status of all responsible projects both in writing and verbally
• Effectively partner with systems engineers and stakeholders of the design controls

Knowledge & Skill:

Design Controls

• Working knowledge of medical device design controls
• Working knowledge of regulatory guidance and general standards (e.g. FDA Guidance on Deciding When to Submit a 510(k), IEC 60601-1, ISO 14971)

MR Safety

• Understanding of MR physics, MR safety and MR testing

General

• Ability to lead complex projects internally and with consultants & contractors
• Ability to work independently on focused initiatives, as well as maintain a collaborative working relationship with software, hardware and compliance engineers, product managers, test engineers, quality, regulatory and other systems engineers

Education/Experience Required:

• Bachelor’s degree in any Engineering discipline and typically 12 years’ experience or equivalent
• 5+ years of experience in systems engineering with medical device design controls and risk analysis methods
• 5+ years of experience in MR Physics, MR safety, and MR testing
• 5+ years of experience working across disciplines (software, hardware, imaging, test, product, marketing, regulatory, quality) in medical device
• Experience managing Design controls database
• Experience with Modern tools for communication and collaborative document creation tools.

Physical Demands:

• This is an onsite position based in Hyperfine’s facility in Guilford, CT
• Ability to travel 10% for conferences, site visits, team building events, etc.
• Available nights, weekends, and holidays when needed

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of any employment Visas at this time.