Usability engineers (Medical Product Usability)

Pentangle Tech Services | P5 Group; Cambridge (MA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Job summary

Pentangle Tech Services | P5 Group is seeking a usability specialist with 2-5 years of progressive experience in healthcare safety. You will apply usability methodologies across the research-to-evaluation lifecycle, reporting results and recommendations to stakeholders.

The role requires collaboration with Design and business teams, mentoring juniors, and willingness to travel globally. Applicants should understand FDA regulations, IEC 62366-1, QSR concepts, risk management, and Agile product

Qualifications

• 2-5 years progressive experience as a usability specialist in Healthcare or safety-related field.
• Initiates and executes own analysis and research to gain deeper insights for redesign and usability requirements.
• Adopts Usability guidelines defined by the Usability Center of Excellence (CoE) and contributes to knowledge management.

Responsibilities

• Lead usability initiatives on high-complexity projects within healthcare safety.
• Collaborate cross-functionally between Design and business stakeholders; onboard juniors and interns; willingness to travel globally.
• Scope and lead larger projects, influence environments to create enabling conditions for success.
• Ensure compliance with FDA regulations and usability standards (IEC 62366-1), risk management, and Agile development.

Skills

Usability methodologies

Stakeholder collaboration

Team mentoring

Travel willingness

FDA regulations

IEC 62366-1

Agile product development

Education

Bachelor’s degree in Design, Industrial Design

Degree in Human Factors Engineering

Human-Computer Interaction

Design Research

Job description

Job Description & Skill Requirement

• At least 2-5 years of progressive experience as a usability specialist in Healthcare or another safety-related field.
• Applies creative expertise on a higher complexity project or program level with a high level of content specialism to maximize patient and staff experience within your focus area by applying your experience of usability methodologies from initial research on user needs to workflow analyses to concept creation to formative evaluations and to summative evaluations.
• Initiates and executes own analysis and research to gain deeper insights as input for solution creation. Report on results, draw conclusions, and identify and communicate recommendations for re-design and usability requirements to relevant business stakeholders.
• Actively drives effective collaboration through co-create approaches between Design and business stakeholders, being able to onboard and guide juniors and interns and willingness and ability to travel to customers globally.
• Leads multi-disciplinary or cross-functional project teams
• Independently scopes and leads larger projects with higher complexity, able to influence the direct environment to create enabling conditions for success
• Follows FDA regulation and usability standards (like IEC 62366-1), understanding of Quality System Regulations (QSR), understanding of Risk Management process, understanding of Agile product development
• Adopts internal Usability guidelines and guardrails that are defined by the Usability Center of Excellence (CoE), as well as contributes to that CoE in knowledge management and stakeholder awareness creation.

Qualification

• Bachelor’s degree in Design, Industrial Design,
• Degree in Human Factors Engineering (HFE), Human-Computer Interaction (HFI)
• Design Research