Sr. Design Quality Engineer

3 weeks ago

New York, United States Hyperfine Full time

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.

#J-18808-Ljbffr

  • Sr. Design Specialist

    1 month ago

    New York, United States USPRO Full time

    Sr. Design Specialist Sterling Heights, MI Duration: 6 month contract Responsibilities: Sr. Designer to support program initiatives. Creates innovative and practical mechanical and electro-mechanical concepts and designs for components, assemblies, tools, and products of varying complexity. Works closely with engineering, vendors, manufacturing, quality, and...

  • Sr. Design and Modeling Engineer

    2 days ago

    New York, New York, United States OWENS CORNING CORPORATE SERVICES LLC Full time

    Sr. Design and Modeling EngineerLocation(s):Granville, OH, US, Function:Research and DevelopmentAudience:Experienced ProfessionalWork Arrangement:On SiteRequisition ID:62382DescriptionThe Sr. Design and Modeling Engineer manages the development, implementation, and support of new technologies related to global advanced modeling operations. This role will...

  • Project Engineer

    3 weeks ago

    New York, United States Engineer Rec Full time

    Our client are seeking Project Engineers for multiple projects along the East Coast, USA. Are you a Project Engineer currently looking for a new challenge and experienced in supporting offshore wind projects? If so please read on. The Project Engineer has the skills and experience to take a leading role related to land and underground installation of high...

  • Project Engineer

    4 weeks ago

    New York, United States Engineer Rec Full time

    Our client are seeking Project Engineers for multiple projects along the East Coast, USA. Are you a Project Engineer currently looking for a new challenge and experienced in supporting offshore wind projects? If so please read on. The Project Engineer has the skills and experience to take a leading role related to land and underground installation of high...

  • Sr. Principal Designer

    5 days ago

    New York, New York, United States KBR Full time

    Title: Sr. Principal Designer - Piping KBR Sustainable Technology Solutions (STS) provides holistic and value-added solutions across the entire asset life cycle. These include world-class licensed process technologies, differentiated advisory services, deep technical domain expertise, energy transition solutions, high-end design capabilities, and smart...

  • Senior Design Quality Engineer

    2 months ago

    New York, United States TransMedics Full time

    TransMedics, Inc., headquartered in Andover, MA, is revolutionizing organ care. With the goal of bringing new life to organ transplant, the pioneering Organ Care System (OCS™) was developed to address the major limitations of the current standard of care, cold storage. The OCS System serves as a portable, miniature intensive care unit that helps preserve...

  • Sr. Software Quality Engineer

    7 days ago

    New York, United States S&P Global Full time

    About the Role : Grade Level (for internal use): 09 The Role: Sr. Software Engineer, Quality Engineering The Team: The Quality Engineering team works in partnership with other Technology Functions and the Business to ensure quality delivery of our products. The team works in an Agile environment and is located globally. The team is independent...

  • Sr Product Designer

    3 weeks ago

    New York, United States Abacus Service Corporation Full time

    Job description: Type of Service Contingent Workforce - Technology Job Title Sr Product Designer Job Description OneMain Financial is the country's largest lending-exclusive financial company, proudly serving millions of customers with safe, affordable, and transparent installment loans. Our customers turn to us every day online and at 1,500 branches in...

  • Sr Product Designer

    3 weeks ago

    New York, United States Abacus Service Corporation Full time

    Job description: Type of Service Contingent Workforce - Technology Job Title Sr Product Designer Job Description OneMain Financial is the country's largest lending-exclusive financial company, proudly serving millions of customers with safe, affordable, and transparent installment loans. Our customers turn to us every day online and at 1,500 branches in...

  • Sr. Electrical Engineer

    6 days ago

    New York, New York, United States Arora Engineers Full time

    Job DetailsJob LocationAEI New York [1EWR]New York, NYDescriptionWe are seeking a Sr. Electrical Engineer (PE Required) for our corporate office based in New York, NY The Sr. Electrical Engineer will be responsible for interpreting, organizing, executing and coordinating engineering projects, as well as the overall design and delivery of services related...

  • Sr Nuclear Engineer

    3 weeks ago

    New York, United States US Tech Solutions Full time

    Job Title: Sr Nuclear Engineer Location: Juno Beach, FL (Remote) Duration: 12+ months contract Job Description: Qualified individual will have previous experience in civil and structural design engineering. This indivi...

  • Sr Nuclear Engineer

    4 weeks ago

    New York, United States US Tech Solutions Full time

    Job Title: Sr Nuclear Engineer Location: Juno Beach, FL (Remote) Duration: 12+ months contract Job Description: Qualified individual will have previous experience in civil and structural design engineering. This indivi...

  • Sr. Design Engineer

    2 months ago

    New York, United States The Wilner Group Full time

    07th May, 2024 The Wilner group has partnered with our client, a family-owned and operated ramp manufacturing and installation company that has a passion for helping those in need. Together we are searching for a Senior Design Engineer to join their team at their Valley Cottage, NY location. This is a full-time, on-site position with a compensation of...

  • Sr. Design Engineer

    1 month ago

    New York, United States The Wilner Group Full time

    07th May, 2024 The Wilner group has partnered with our client, a family-owned and operated ramp manufacturing and installation company that has a passion for helping those in need. Together we are searching for a Senior Design Engineer to join their team at their Valley Cottage, NY location. This is a full-time, on-site position with a compensation of...

  • Sr. Design Engineer

    3 weeks ago

    New York, United States The Wilner Group Full time

    07th May, 2024 The Wilner group has partnered with our client, a family-owned and operated ramp manufacturing and installation company that has a passion for helping those in need. Together we are searching for a Senior Design Engineer to join their team at their Valley Cottage, NY location. This is a full-time, on-site position with a compensation of...

  • Sr. Design Engineer

    2 weeks ago

    New York, United States The Wilner Group Full time

    10th June, 2024 The Wilner group has partnered with our client, a family-owned and operated ramp manufacturing and installation company that has a passion for helping those in need. Together we are searching for a Senior Design Engineer to join their team at their Valley Cottage, NY location. This is a full-time, on-site position with a compensation of...

  • Sr. Renewables Electrical Engineer, Solar

    2 months ago

    New York, United States ThinkBAC Consulting Full time

    Job DescriptionJob DescriptionThis is a remote position.Sr. Renewables Electrical Design Engineer, Solar and EV - REMOTE (Howell, NJ area)We are working with a comprehensive engineering services provider that has a specialized focus in Solar, Electric Vehicle (EV), and Civil Engineering disciplines. The company provides end-to-end engineering services from...

  • Sr. Renewables Electrical Engineer, Solar

    2 weeks ago

    New York, United States ThinkBAC Consulting Full time

    Job DescriptionJob DescriptionThis is a remote position.Sr. Renewables Electrical Design Engineer, Solar and EV - REMOTE (Howell, NJ area)We are working with a comprehensive engineering services provider that has a specialized focus in Solar, Electric Vehicle (EV), and Civil Engineering disciplines. The company provides end-to-end engineering services from...

  • Sr. RF Engineer

    2 months ago

    New York, United States USPRO Full time

    Sr. RF Engineer Berlin, CT Direct Hire Responsibilities and Qualifications: Minimum 5-10 years of experience in RF systems design, doppler radar, radio communications systems Designing PCB board for RF systems, integrating subsystems and design of full RF and radar systems 0-50 GHz. Knowledge of system level RF design from development to full manufacturing...

  • Sr. Software Engineer

    5 days ago

    New York, New York, United States INSPYR Solutions Full time

    Sr. Software Engineer - Long Term Project - Remote (Specified Locations)Title: Sr. Software EngineerLocation: Remote (Based in LA, NYC, Seattle, Orlando or Houston)Duration: Long Term Project Compensation: $75-95/hrWork Requirements: US Citizen, GC Holders or Authorized to Work in the USQualified candidates may send a copy of their resume (Word Format) to ...