Summary
Overview
Work History
Education
Skills
Websites
Certification
Expertise Tools
Publications
Training
Timeline
Generic

Junitha Michael

Thousand Oaks,CA

Summary

  • Human Factors/Usability Engineer (HF/UE) with 15+ years of experience in leading usability and user research activities for medical devices, disposables, pharmaceutical and combination products, embedded medical device softwares, and software as medical device (SaMD). Experienced leader with proven ability to effectively lead/mentor HF Engineers to meet organizational needs. Effectively communicated with end users; technical and non-technical team members; senior management; auditors and regulators

Overview

16
16
years of professional experience
1
1
Certification

Work History

Principal Human Factors/Usability Engineer

Amgen Inc.
08.2021 - Current
  • Lead team of 5-6 Human Factors (HF) Engineers and Instructional Designers to support HF activities for development of combination and non-combination devices/systems (Pre-filled syringes, auto-injectors, wearables/On-body injectors, ampules/vials, software applications including Augmented Reality (AR) apps both iOS and Android)
  • Develop user-centered design thinking as a core competency within the company providing world class user engagement and significant competitive advantage
  • Develop HF and Instructional Design strategies for combination product design and development from feasibility, clinical development, through product registration, and post-market surveillance
  • Serve as SME, establish and continuously access gap in HF standard operating procedure (SOP) and templates against latest regulations/standards
  • Educate team members, and other internal stakeholders, on the overall HFE development process and fit-for-purpose approach
  • Mentor/coach team with planning usability studies, analysis of known use problems (KUPs), preparing HF documentation (Plan, Context of Use, Use Specification, Task Analysis (TA), Use related Risk Analysis (URRA), Technical Assessments), participant recruitment, study design, data analysis, and report writing for regulatory submissions
  • Expertise in conducting Formative and Summative HF studies, interviews, diary studies, user workshops, contextual inquiry/ethnography, surveys, and logs analysis as well as performing Threshold Analyses
  • Regularly interface and coordinate with HF consulting firms to execute HF engineering activities, provide program management oversight and scale utilization; ensure technical writing outcomes and deliverables are achieved according to project goals/milestones
  • Interface with Clinical, Compliance, Privacy, Legal, Marketing, Design Engineering, Quality, Labeling, Regulatory, Packaging, and Manufacturing to produce user centered designs that not only meet user needs but also factor in business priorities and platform, and manufacturing constraints
  • Work closely with Instructional Designers to develop instructions for use (IFU), quick reference guides (QRG), prescription information (USPI), packaging design, educational videos and ancillary materials
  • Represent HF function during internal and external audits; interface with Notified bodies and Regulatory Agencies during Protocol reviews, and Submission reviews
  • Plan and conduct worldwide customer and competitive industry research to identify and prioritize usability improvement possibilities and solutions
  • Interface with end-users (physicians,
    nurses, pharmacists, pharmacy technicians, adult as well as adolescent patients and caregivers) and conduct usability
    research
  • Remain current on and develop expertise in developments in HF, applicable regulatory requirements and restrictions, and a general knowledge of the company’s products, markets, policies, and objectives as well as industry trends
  • Strategize and develop implementation plan (UX requirements, timelines, budget, resourcing) and present to executive and senior leadership
  • Ensure all HF work is performed in accordance with SOPs and applicable regulatory requirements

Senior Human Factors/Usability Engineer

Amgen Inc.
10.2017 - 08.2021
  • Led HF and industrial design activities for development of drug delivery devices/systems considering all aspects of the user, including the intended user, the user environment, and the drug therapy being delivered
  • Applied knowledge of human performance (perceptual, cognitive, motor skills) and HF techniques on wide variety of products
  • Conducted Heuristic evaluation to determine usability positives and opportunities for improvements
  • Conducted ethnographic research and task analysis to determine workflow of admixing and preparing oncology IV administration bags under USP-797 laminar hood
  • Mentored and guided junior engineers to meet their HF objectives and deliverables
  • Provided HF support across product lifecycle including user needs identification, development of user profiles, use environments, use scenarios, TA-URRA, generation of hardware and software design concepts, user interface design, usability testing, and HF engineering reports
  • Developed usability improvement concepts and worked across product lines to create and manage usability improvement plans and usability standards
  • Prepared and presented to appropriate program or functional teams and individuals on HF scope, plan, risks and mitigation strategies
  • Strong background in understanding user characteristics, anticipating potential use errors, discovering unanticipated use errors and develop design mitigations
  • Worked closely with software developers to develop wireframe for software applications, conduct cognitive walkthrough of early prototypes with users, identified potential solutions and provided feedback to developers for optimization
  • Designed, developed and conducted usability testing to validate combination product safety and usability (develop Plan/Protocol including Moderator Guide, User Questionnaire; perform data analysis; present data to cross-functional teams; develop high-level summary of research as well as Usability Summary Report)

V&V Project Manager

Hospira Inc., a Pfizer Company/ICU Medical
07.2015 - 09.2017
  • Led 15-20 Design Verification and Validation (V&V) Engineers across the globe to support multiple platforms (large volume infusion pumps and disposables)
  • Planned, designed, and scheduled phases for complex V&V projects, led proposals, managed excellent client relationships with vendors
  • Facilitated multi-specialty end-user workshops/focus groups to identify user needs/use cases
  • Managed and presented anticipated timeline/resource/budget constraints as well as potential mitigations to management bi-weekly
  • Provided detailed technical and operational direction in project challenges, consistently meeting deliverables according to deadlines to stakeholders and executive management

Sr. Systems Engineer (Design Validation)

Hospira Inc.
10.2012 - 07.2015
  • Led 6-8 Design Validation Engineers and delivered Validation documents to support 8
    Traditional 510(k) submissions, 4 Health Canada submissions and 3 CE Mark Certifications
  • Provided HF solutions to
    design; develop and validate infusion pumps, disposables and drug-device combination devices
  • Performed Task and workflow analyses as well as conducted UERA
  • Designed, developed and conducted usability validation testing to validate product
    safety and usability
  • Conducted and analyzed usability
    validation studies     with physician,
    nurses, pharmacy technicians and biomedical technicians
  • Implemented HF solutions in creating System Operating Manual (SOM), Technical Specifications Manual (TSM), Instructions for Use (IFU), Carton/Package labels
  • Provided device usability input to develop design inputs and specifications
  • Remediated multiple product lines (Disposables/Drug-device combination devices, Infusion Pumps)

    worth of 2 billion dollars revenue
  • Managed Usability
    validation activities with HF vendors, including on boarding of HF vendor, generation of study brief, acquire HF vendor proposal, assignment of HF vendor, provide study materials, manage studies and generation and approval of reports
  • Reported any adverse findings or failures observed during interviews/surveys/studies
    and
    ensured appropriate action; ensured timely execution of studies
  • Managed study expenses; internal resources allocation and client/vendor communications

Device Design Validation Lead

Hospira Inc.
08.2011 - 10.2012
  • Developed design validation templates (Plan, Protocol, and Report)
  • Validated infusion pumps, related disposables products and accessories
  • Designed simulated usability study suite to mimic actual work conditions to aid usability data collection; set-up to observe participants through one-way mirror; real-time communication with moderator during study
  • Developed user-friendly questionnaires, focus group protocols and interview guides to enhance effective data collection

Validation Specialist

Nobel Biocare Procera LLC
11.2010 - 08.2011
  • Provided HF solutions to Software developers of Restorative dental softwares
  • Developed and ensured execution of V&V strategy to assure products meet intended use - dental scanner and dental treatment planning softwares
  • Completed ISO 13485:2003 Compliance Internal Auditor certification

Software QA Engineer (Contractor)

Bausch & Lomb Inc.
01.2010 - 11.2010
  • Authored Validation Master Plan and associated deliverables to implement Laboratory Management System (LIMS)
    upgrade (SDLC
    and STLC)
    and performed audit trails to ensure DHF compliance
  • Validated LIMS upgrade and reviewed test scripts post-execution to identify any deviations and follow-up actions

Product Integrity Engineer

Evenflo Company Inc.
05.2008 - 11.2008
  • Significantly improved customer complaints data collection and handling utilizing human factors techniques which led to efficient root-cause analysis and reduced product returns
  • Authored Special 510(k) & Health Canada License approval on Evenflo breast pumps

Education

M.S Industrial & Human Factors Engineering -

Wright State University
Dayton, OH
01.2008

M.S. Biomedical Engineering -

Wright State University
Dayton, OH
01.2006

B.S. in Instrumentation & Control Engineering -

University of Madras
01.2004

Skills

  • Formative and Summative HF studies
  • SOP and templates
  • Cognitive walkthrough
  • Product Development
  • Root Cause Analysis
  • Study moderation
  • Process Improvement
  • Threshold Analyses
  • Task Analyses
  • Critical thinking
  • Design optimization

Certification

ISO 13485:2003 Compliance Internal Auditor, 04/2011, Delpha Quality Consulting

Expertise Tools

Live + Remote Usability Studies, Design sprint facilitator, IEC 62366-1:2015-02+ Amendment 1: 2020, ISO – 14971: 2019, ANSI/AAMI HE75: 2009/(R)2018, ISO 13485, MDD 93/42, EU MDR regulations, cGxP, IEC 60601, FDA guidances, Applying HF and Usability Engineering to Medical Devices, HF studies and related Clinical Study considerations in Combination Product design and development, Contents of a complete Submission for Threshold Analyses and HF submissions to drug and biologics application, 21 CFR Part - 11, 210, 211 & 820, Adobe Illustrator, InDesign, Instron, DFMEA, uFMEA, 5S, JIRA, TrackWise, DOORS

Publications

Biomechanics of the ankle joint and clinical outcomes of total ankle replacement, Journal of the Mechanical Behavior of Biomedical Materials, Vol 1, Issue 4, 10/2008

Training

Lean-Ergonomics for Manufacturing, 06/2008, Wright State University, OH Advanced Course - Human Factors for the Usability of Medical Devices, 04/2019, On-site training by former FDA HF experts AAMI Webinar: Design Considerations for An Aging Population, 11/2017, AAMI AAMI Course: Human Factors for Medical Devices, 01/2018, AAMI

Timeline

Principal Human Factors/Usability Engineer

Amgen Inc.
08.2021 - Current

Senior Human Factors/Usability Engineer

Amgen Inc.
10.2017 - 08.2021

V&V Project Manager

Hospira Inc., a Pfizer Company/ICU Medical
07.2015 - 09.2017

Sr. Systems Engineer (Design Validation)

Hospira Inc.
10.2012 - 07.2015

Device Design Validation Lead

Hospira Inc.
08.2011 - 10.2012

Validation Specialist

Nobel Biocare Procera LLC
11.2010 - 08.2011

Software QA Engineer (Contractor)

Bausch & Lomb Inc.
01.2010 - 11.2010

Product Integrity Engineer

Evenflo Company Inc.
05.2008 - 11.2008

M.S Industrial & Human Factors Engineering -

Wright State University

M.S. Biomedical Engineering -

Wright State University

B.S. in Instrumentation & Control Engineering -

University of Madras

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