Hyperfine
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.Learn More
About The Role
Job Title: Design Quality Engineer 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. Key Responsibilities
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. Knowledge, Skill & Abilities
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 fast-paced environment; ability to work well under pressure and maintain a positive, enthusiastic, and problem-solving attitude. Computer literate in various software applications (Word, Excel, PowerPoint, Minitab, Jira). Independent organization and prioritization of multiple tasks. Required Education & Experience
BS in Engineering (Mechanical, Biomedical preferred) or related technical field (MS in Science/Engineering preferred); or equivalent experience. ASQ, CQE or CSSBB preferred. 5 years related work experience in Engineering or Quality role. 3 years of experience in team-based medical device product development. Knowledge of all aspects of medical device design, including voice of customer and design requirements, verification and validation, process validation, and design transfer to manufacturing. Preferred Qualifications
Experience with Medical Imaging devices. Experience with software including machine learning applications. Experience with electromechanical devices with SAAM and procedures. Physical Demands
This is a full-time, on-site position at Hyperfine’s facility in Guilford, CT. Travel up to 10% of the time for business needs (e.g., site visits). Available nights, weekends, and holidays when needed. Ability to occasionally lift up to 50lbs. Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship now or in the future of any employment Visa. The annual base salary for this position is between $110,000 - $125,000. This position is also eligible to participate in Hyperfine's corporate bonus and equity plans. Individual compensation packages are based on various factors unique to each candidate, including skill set, relevant experience, qualifications, location, position level, and other job-related reasons. Create a Job Alert Interested in building your career at Hyperfine? Get future opportunities sent straight to your email. Apply for this job
* indicates a required field First Name * Last Name * Preferred First Name Email * Phone * Resume/CV * Enter manually Accepted file types: pdf, doc, docx, txt, rtf This position is a full-time, on-site role in Guilford, CT. Are you currently located within reasonable commuting distance and able to work onsite full-time? * Select... Are you legally authorized to work in the United States for any employer, and will you now or in the future require visa sponsorship (e.g., H-1B, F-1 OPT, etc.) to continue working in the U.S.? * Select... How did you hear about this job? If referred, please list the employee's name. LinkedIn Profile Voluntary Self-Identification
For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. As set forth in Hyperfine’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A disabled veteran is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A recently separated veteran means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An active duty wartime or campaign badge veteran means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An Armed forces service medal veteran means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Select... Voluntary Self-Identification of Disability
Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.
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Job Title: Design Quality Engineer 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. Key Responsibilities
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. Knowledge, Skill & Abilities
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 fast-paced environment; ability to work well under pressure and maintain a positive, enthusiastic, and problem-solving attitude. Computer literate in various software applications (Word, Excel, PowerPoint, Minitab, Jira). Independent organization and prioritization of multiple tasks. Required Education & Experience
BS in Engineering (Mechanical, Biomedical preferred) or related technical field (MS in Science/Engineering preferred); or equivalent experience. ASQ, CQE or CSSBB preferred. 5 years related work experience in Engineering or Quality role. 3 years of experience in team-based medical device product development. Knowledge of all aspects of medical device design, including voice of customer and design requirements, verification and validation, process validation, and design transfer to manufacturing. Preferred Qualifications
Experience with Medical Imaging devices. Experience with software including machine learning applications. Experience with electromechanical devices with SAAM and procedures. Physical Demands
This is a full-time, on-site position at Hyperfine’s facility in Guilford, CT. Travel up to 10% of the time for business needs (e.g., site visits). Available nights, weekends, and holidays when needed. Ability to occasionally lift up to 50lbs. Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship now or in the future of any employment Visa. The annual base salary for this position is between $110,000 - $125,000. This position is also eligible to participate in Hyperfine's corporate bonus and equity plans. Individual compensation packages are based on various factors unique to each candidate, including skill set, relevant experience, qualifications, location, position level, and other job-related reasons. Create a Job Alert Interested in building your career at Hyperfine? Get future opportunities sent straight to your email. Apply for this job
* indicates a required field First Name * Last Name * Preferred First Name Email * Phone * Resume/CV * Enter manually Accepted file types: pdf, doc, docx, txt, rtf This position is a full-time, on-site role in Guilford, CT. Are you currently located within reasonable commuting distance and able to work onsite full-time? * Select... Are you legally authorized to work in the United States for any employer, and will you now or in the future require visa sponsorship (e.g., H-1B, F-1 OPT, etc.) to continue working in the U.S.? * Select... How did you hear about this job? If referred, please list the employee's name. LinkedIn Profile Voluntary Self-Identification
For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. As set forth in Hyperfine’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A disabled veteran is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A recently separated veteran means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An active duty wartime or campaign badge veteran means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An Armed forces service medal veteran means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Select... Voluntary Self-Identification of Disability
Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.
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