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Human Factors Use Experience Design Engineer

TFS

Human Factors Use Experience Design Engineer

Brea, CA
Full Time
Paid
  • Responsibilities

    Human Factors Use Experience Design Engineer

    • SKILLS AND CERTIFICATIONS
      User Interfaces
      Human Factors
      SolidWorks
    • Security Clearance Required: No
    • Visa Candidate Considered: No
    • COMPENSATION
    • Full-time
    • Benefits - Full
    • Relocation Assistance Available - No
    • Commission Compensation - No
    • Bonus Eligible - No
    • Overtime Eligible - No
    • Interview Travel Reimbursed - No

    CANDIDATE DETAILS

    7+ to 10 years experience

    Seniority Level - Mid-Senior

    Management Experience Required - Yes

    Minimum Education - Bachelor's Degree

    Willingness to Travel - Occasionally

     

    Industry: Medical Equipment / Devices

    Job Category: Information Technology - Business Intelligence

    The ideal candidate for this role is passionate about design for user experience with proven capabilities in visual design, information architecture, and interaction design for both standalone software and integrated software/hardware solutions. They have a passion for interacting with customers and doing user research to drive the human factors engineering process. They also enjoy leading innovation workshops and working with global multi-functional teams to aim to a diversified and high-quality solution set using principles in design thinking.

    The HF+UXD Team works within the MDS Center of Excellence (COE). The goal of COE is to stimulate and lead concept and technology innovation spanning multiple product platforms. The role of HF+UXD within this group is to bring knowledge and expertise in user-centered design that begins with the initiation of programs and transitions into design and development. The HF+UXD engineer will have the opportunity to engage in numerous MDS product development programs across the MDS COE and 4 business groups – New Ventures in Franklin Lakes NJ, Catheter Care and Medication Delivery (CCMD) in Franklin Lakes NJ, Vascular Access Devices (VAD) in Salt Lake City UT, and Infusion Specialty Disposables (ISD) in San Diego and Brea CA. They will also serve as a key partner and contributor to the MDS Lean Engineering group that works to optimize engineering tools, best practices, and R&D procedures across MDS.

    Responsibilities:

    The Sr. Staff HF+UXD engineer will serve as a strategic and executional leader across the MDS business for human factors engineering and user experience design – engaging in product design work and independent review, including the following:

    • Usability Strategy, Planning, & Execution:
      • Strategize with multi-functional core teams and leaders to ensure human factors and usability design strategies and plans are appropriately scaled across multiple and/or sophisticated high impact, business critical programs.
      • Execute HF+UXD results for key programs by working independently, supervising the execution of others, managing the work of external vendors, and collaborating with project teams to ensure high quality deliverables.
    • Generative Research & Front-End Innovation:
      • Partner and collaborate with front end innovation teams to conduct generative research including but not limited to observational research (contextual inquiry and ethnography), driven usability assessment, subject matter expert (SME) and key opinion leader (KOL) interviews, focus groups, and surveys.
    • Design Thinking, Human Factors, & Usability Engineering Tools:
      • Lead Innovation Workshops with small and large multi-functional or technical teams that focus on a variety of subjects including insights distillation, concept generation, or solutions optimization to improve safety and/or user delight.
      • Drive understanding of the human-system interface through the creation of user profiles, environmental characterization, workflow mapping, task analysis, functional modeling, use cases / scenarios, and more.
      • Apply 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 advise user needs, user risk, and user interface design through processes such as KJ Analysis or Affinity Diagrams.
      • Have a deep understanding of the requirements management process that focuses on the creation of user needs to influence standard methodologies across multi-functional teams and leaders.
      • Evaluate Use Error as part of use-related risk analysis (URRA, aEURA, uFMEA, and/or Hazard Analysis) and contribute to mitigation efforts in partnership with medical affairs and multi-functional teams.
    • Design of Digital & Physical User Interfaces:
      • Design and develop user interfaces which include but are not limited to devices, digital solutions, packaging, instructions, and training.
      • Create digital user interface designs using low and high-fidelity prototyping tools for a variety of software environments and platforms including desktop, mobile, embedded systems, and web.
      • Partner with thought leaders to advance BD solutions for customers and product development teams in areas such as design for a system of systems ecosystem and data collection and analytics.
    • Formative Evaluation, Design Validation, and Summative Human Factor Validation:
      • Design, plan, implement, analyze, and report using qualitative and quantitative research as part of formative study evaluation which may include heuristic evaluation, expert review, simulated use studies, and actual use studies.
      • Serve as executional lead and/or the contact for external vendors and business group Verification & Validation (V&V) teams during Design Validation and Summative Human Factors Validation Testing.
      • Partner with internal and external teams such as Global Clinical Development, Pre-Clinical Development, and Medical Affairs to perform Pre-Clinical and Clinical Studies.

    In addition to program responsibilities, this role will also work to lead efforts to educate and improve human factors engineering and user experience design throughout the BD community. They will accomplish this by doing work that exemplifies best practices, mentoring other engineers within HF+UXD and on project teams, participating in and holding training/workshops, and providing constructive challenge to MDS and cross-business teams as independent reviewers and advocates of the customer and end-user.

    A key characteristic of an associate in this role is an all-in, get-your-hands-dirty approach that continues to persevere and find allies even when faced with obstacles. The associate should be able to figure out how to prototype a concept quickly, in sometimes non-traditional ways, to get a quick reaction or test feasibility with end users to enable Agile development.

    Skills:

    Required:

    • 6-10+ years of technical experience
    • Bachelor’s Degree in a technical field (human-computer interaction preferred)
    • Deep understanding of applicable standards and industry guidance for medical devices and usability engineering including IEC 62366-1, FDA Guidance for Human Factors (2016), IEC 62366-2, HE75, ISO 13485, FDA Guidance for Design Controls, & ISO 14971
    • A minimum of 5 years experience performing and leading/managing the work of outside partners and/or internal team members related to digital human-systems interface design and usability research/testing strategy and execution.
    • Mastered at least one of the following to support innovation, design, and development:
      • Sketching or Graphic Design
      • 3D Modeling, Drafting, and Physical Prototyping (SolidWorks Preferred)
      • Wireframing and Digital Prototyping (Adobe XD and Axure preferred)
      • Technology Development in areas such as Mechanical, Electrical, or Software Engineering
    • Demonstrated creation of new concepts and Intellectual Property (IP)

    Preferred:

    • Master’s Degree or PhD in a technical field (human-computer interaction, systems engineering, human factors engineering, mechanical engineering, industrial design, or biomedical engineering preferred)
    • 5+ years of experience working with medical devices
    • Highly motivated self-starter able to influence teams, leaders, and key program partners
    • Mastery of written and verbal communication skills, with ability to present sophisticated ideas to multiple levels
    • Professional creative, analytical and problem-solving skills
    • Experienced level technical judgement, leadership, and interpersonal skills
    • Experienced facilitation and analytic skills with an open mind
    • Extensive knowledge of engineering first principles
    • Mastery of the End-to-End Product Development Process