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Malt Strategy
Liset R.LR

Liset R.

Human Factors Development Engineer

€931/day
Bristol, GB
3-7 years

Average response time: 1 hour

About Liset

With over 6 years of expertise in Human-Centred Design within the medical device industry, I bring a profound commitment to integrating human factors into the heart of the design process. My passion lies in ensuring that products not only meet the highest standards of safety and efficacy but are also inherently intuitive and appealing to users.

I thrive in collaborative environments, particularly when working closely with Research and Development teams to tackle intricate challenges. My goal is to contribute to the creation of exceptional outcomes by leveraging a comprehensive understanding of human factors.

In supporting your team, I am knowledgeable in fulfilling Human Factors Engineering (HFE) requirements. I can take ownership of key work packages, encompassing HFE Planning, Use Specification, Use-Related Risk Assessments (URRAs), Threshold Analysis, Usability Formative Planning (including Recruitment Screener, Protocol, Moderating, Data Capturing, Observing, Root Cause Analysis (RCA), Data Analysis, and Reporting).

By seamlessly integrating human-centred principles into the design process, I am confident in my ability to enhance the quality and usability of your products. I look forward to the opportunity to contribute my skills and experience to your team's success.
Medical Devices

  • Spanish

    Native or bilingual

  • English

    Native or bilingual

Can work on-site
Bristol (up to 30km)

Experience

  • Recipharm
    Senior Human Factors Engineer
    TECH
    February 2023 - Today (3 years and 4 months)
    King's Lynn, United Kingdom
    o Responsible for applying human factors techniques to support the development of medical devices, in compliance with relevant regulatory standards (IEC62366, FDA guidance, ANSI/AAMI HE75).
    o Generate usability related documentation defining user profiles, task analyses, user interface requirements, and use-related risk analysis to support new product developments.
    o Facilitate formative and summative usability evaluations by writing study protocols, moderating sessions, collecting data, and generating study reports to document findings, data analysis, and recommendations.
    o Disseminate studies and research results to stakeholders, by generating engaging presentations.
    o Apply good research practices, such as obtain informed consent and follow data privacy regulations.
    o Deliver high quality human factors projects on time and on budget.

    Human factors engineering IEC62366 FDA guidance ANSI/AAMI HE75 Human Centred Design Process
  • Recipharm
    Product Development Engineer
    MECHANICAL ENGINEERING
    September 2017 - February 2023 (5 years and 5 months)
    King's Lynn, United Kingdom
    o Responsible for product development activities related to the design of drug device combination products for intranasal, inhalation, and injectable routes of administration.
    o Create CAD models and drawing specifications of components, prototypes, and assemblies.
    o Perform mechanical assessments using mathematical formulas, physical laws, engineering models, tolerance stacks, design of experiments and finite element analysis (FEA).
    o Support risk management activities including Fault Tree Analysis, Hazard Analysis and Failure Mode & Effects Analysis, in compliance with associated regulatory standards (ISO14971, FDA guidance).
    o Work with cross-functional teams to complete Design for Manufacture and Assembly activities, to guarantee suitability of products for commercial production.
    Drug Delivery Medical Devices CAD Product design ISO14971 FDA Guidance Human Centred Design Process Mechanical Engineering
  • Zimmer Biomet
    Manufacturing Engineer
    MECHANICAL ENGINEERING
    May 2015 - July 2016 (1 year and 3 months)
    Warsaw, United States
    o Responsible for continuous improvement and quality compliance of manufacturing processes related to orthopaedic implants.
    o Completed process validation activities including process capability studies, IQs, OQs, and PQs.
    o Generated and implemented verification procedures for monthly process monitoring.
    o Participated in CAPA activities to identify and resolve areas in need of corrective and preventing actions.
    o Created and maintained production documentation such as Measurement Instruction Sheets, drawings, Operating Procedures, Work Instructions, Failure Mode & Effect Analysis, Bill of Materials, and Design Master Record.
    Medical devices Lean six sigma Engineering Drawings Operating Procedures Bill of Materials FMEA Process Validation Work Instructions

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Education

  • Bachelor of Science in Biomedical Engineering
    Florida International University, USA
    2014
    Biomedical Engineering is a field that applies physical, chemical, mathematical, computer science and engineering principles to the analysis of biological, medical, behavioural, and health-related problems. Biomedical engineers develop innovative devices and procedures to help prevent, diagnose, and treat diseases.
  • Master of Engineering Science in Product Design and Management
    University of Liverpool, UK
    2017
    The MSc in Product Design and Management provided advanced training in all aspects of product design, focusing on subjects required to develop reliable products with high quality and user satisfaction.

Certifications

Skill set (45)

Human-centred design process
User Interface Design
User needs
User Requirements
Product Requirements
User Research
IEC 62366
ISO 14971
ISO 13485
FDA Guidances
Formative Usability Evaluations
Threshold Analysis
CAD
Engineering Drawings
FMEAs
User Testing
Prototype
Design Thinking
Product design
Data analysis
Use Specification
User Interface Plan
User Interface Specification
Use Risk Analysis
HFE Summary Report
Formative
Task Analysis
PCA Analysis
Database searches (Known use risks)
Use Related Risk Analysis
Human factors engineering
IEC62366
FDA guidance
ANSI/AAMI HE75
Human Centred Design Process
Drug Delivery Medical Devices
ISO14971
Mechanical Engineering
Medical devices
Lean six sigma
Operating Procedures
Bill of Materials
FMEA
Process Validation
Work Instructions

Categories