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Hyperfine | AI-Powered Portable MRI · 2 months ago

Design Quality Engineer

Guilford, CT

Full-time

Onsite

Mid, Senior Level

$110K/yr - $125K/yr

5+ years exp

Hyperfine, Inc. is a groundbreaking health technology company that has redefined brain imaging with the Swoop® system. The Design Quality Engineer will collaborate with a cross-functional New Product Development team to ensure product performance, safety, and compliance with regulatory and quality requirements, while driving improvements in design processes and products.

Medical Device

No H1B

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

Qualification

Design ControlsFDA complianceIEC 62304Design of ExperimentsAgile software developmentGD&TStatistical analysisRelationship managementComputer literacyIndependent organizationEffective communicationProblem solvingLeadership skillsTeam collaboration

Required

Collaboration and successful communication within a cross-functional New Product Development (NPD) team

Comprehensive knowledge, leadership, and analytical skills to contribute to the development of new products and modification of existing products

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

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 (i.e. - Word, Excel, PowerPoint, Minitab, Jira)

Independent organization and prioritization of multiple tasks

BS in Engineering (Mechanical, Biomedical preferred) or related technical field (MS in Science/Engineering preferred); or equivalent experience

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