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Design Assurance Director
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Design Assurance Director
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Integra LifeSciences Mansfield, United StatesChanging lives. Building Careers. · Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's pos ...
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Design Assurance Director
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Design Assurance Director
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Design Assurance Engineer
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National Grid plc Warwick, United StatesPress Tab to Move to Skip to Content Link · Select how often (in days) to receive an alert: · HV Design Engineer - Assurance, England or Wales · Location: · Warwick, GB, CV34 6DA · Job Type: · Requisition Number: · 52871 · Department: · Electricity Transmission - Operations ...
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Sr. Design Quality Assurance Engineer
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Quality Engineer, Design Assurance
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Senior Design Assurance Engineer
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Principal Software Design Assurance Engineer
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Design Assurance Engineer- Medical Device
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CEI Group Woburn, MA, United StatesDesign Assurance Engineer · Responsibilities: · Ensuring that the design process complies with relevant regulations and standards such as FDA guidelines, ISO standards, and other applicable regulatory requirements. · Working with the verification and validation efforts to ensur ...
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Sr. Design Quality Assurance Engineer
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Senior Project Quality Manager
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Lead Protection and Control Engineer
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Senior Engineer, Quality Design Assurance - Mansfield, United States - Integra LifeSciences
Description
The HF+UXD engineer will serve as an individual contributor to Integra LifeSciences project teams for human factors engineering and user experience design – engaging in product design work and independent review, including the following:Usability Planning & Execution:
Collaborate with cross functional core teams to ensure human factors and usability plans are appropriately scaled.
Execute human factors and user experience design deliverables by working with minimal supervision, managing the work of external vendors, and consulting with project teams to ensure quality deliverables.
Support project teams in execution of deliverables associated with closing gaps in project usability files.Human Factors & User Experience Tools:
Drive understanding of the human-system interface through the creation of user profiles, environmental characterization, workflow mapping, task analysis, functional modeling, and use cases / scenarios.
Utilize anthropometry, biomechanics, and human capability data to support, analyze, and optimization system design and ergonomics.User Needs/Requirements & User Risk Assessment:
Distill research insights into themes that inform user needs, user risk, and user interface design through processes such as affinization or KJ Analysis to ensure traceability.
Have working understanding of the requirements management process that focuses on the creation of user needs and stakeholder requirements as part of a cross-functional team.
Evaluate Use Error as part of use-related risk analysis (aFMEA, and/or Hazard Analysis) and contribute to mitigation efforts in partnership with medical affairs and cross-functional teams.
Design of User Interfaces:
Support design and development of user interfaces which include but are not limited to devices, software, packaging, instructions, and training.
Conduct product evaluations, brainstorming sessions, competitive analysis, and other usability engineering methodologies with internal teams and external vendors.
Utilize low to high fidelity prototyping methods to enable quick turn customer centric design loops that power Agile processes and decision making.
Generative Research & Front-End Innovation:
Participate as a member of the experience teams to conduct generative research including but not limited to observational research (contextual inquiry and ethnography), competitive usability assessment as required.
Design, plan, execute, analyze, and report using qualitative and quantitative research as part of formative study evaluation which may include but are not limited to heuristic evaluation, expert review, simulated use studies, and actual use studies.
Serve as support, executional lead, and/or contact for external vendors and business group Verification & Validation (V&V) teams during Design Validation and Summative Human Factors Validation.
Partner with internal and external teams such as Global Clinical Development, Pre-Clinical Development, and Medical Affairs to perform Pre-Clinical and Clinical Studies, as needed.
In addition to program responsibilities, the HF+UXD engineer will also work to support efforts to educate and improve human factors engineering and user experience design throughout the Integra LifeSciences community.
They will accomplish this by doing work that exemplifies best practices, influencing other engineers on project teams, participating in and helping with training/workshops, and providing constructive challenge primarily to teams as independent reviewers and advocates of the customer and end-user.
EXPERIENCE & EDUCATION:
5+ years of technical experience, with demonstrated success in leading teams engaged in research technology and/or product development (medical device industry preferred).
Bachelor's Degree in a technical field (human factors engineering, biomedical engineering, mechanical engineering, industrial design) with a minimum of 8 years of industrial experience.
Master's Degree in a technical field (human factors engineering, biomedical engineering, mechanical engineering, industrial design) with a minimum of 5 years of industrial experience.
Minimum of 2 years of experience in a user interface and/or human factors engineering role (preferred)Core knowledge of applicable standards and industry guidance for medical devices and usability engineering including:
IEC , FDA Guidance for Human Factors (2016), ISO 13485, FDA Guidance for Design Controls, ISO 14971
Capable of performing usability studies and translating HF+UXD findings into user-needs/requirements, user risk, and/or design solutions related to the user interface.
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