Design Quality Engineer
Design Quality Engineer
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$ 110000 - 125000
1 Vacancy
Job Description
About Us
Hyperfine Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with theSwoopsystemthe 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
Location: Guilford CT USA
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 Hyperfines 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 Hyperfines 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 (i.e. - 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 Hyperfines 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 $110000 - $125000. This position is also eligible for to participate in Hyperfines 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.
AgencyResumes:
Employment Type
Full Time
