Senior Manager of Human Factors and User Experience at Boston Scientific Corporation Malaysia

Cambridge, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

05 Feb, 26

Salary

0.0

Posted On

07 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Human Factors Engineering, User Experience, Usability Evaluations, Design Reviews, Risk Management, Workflow Analysis, Usability Risk Management, Team Leadership, Project Management, Regulatory Compliance, Cognitive Analysis, Physical Context Analysis, Situational Context Analysis, Quantitative Data Analysis, Qualitative Data Analysis, Critical Thinking

Industry

Medical Equipment Manufacturing

Description

Develop and Communicate a vision and strategy for Human Factors Engineering at EP Lead a team that is responsible for the execution of Human Factors within the projects Collaborate with systems owners and (overall) responsible designers to incorporate Human Factors Engineering (HFE) input into the design Manage an Operational Experience Review process to include the lessons learned from previous designs Responsible for ensuring that the implementation of the Human Factors program is done correctly Work with global cross-functional teams on the creation of excellent user and patient experience for BSC EP devices, ensuring safe and effective use. This involves working on all stages of the User-Centered product development process; from contribution to the initial research on user needs and workflow analyses, to providing usability evaluations for soon-to-be released products. Create and execute usability evaluation plans within the team to be performed across design and development of our products. Such activities are defined in cooperation with internal stakeholders in the Business Units, peers, and with global functions, and executed according to current standards on usability engineering to ensure compliance with European and American regulations (i.e. FDA). Conduct usability evaluations (formative and summative), expert reviews, and heuristics evaluations using established usability practices and methods—reporting results, drawing conclusions and making recommendations for re-design and usability requirements. Secure high-quality usability (usability safety, effectiveness, efficiency, and customer satisfaction in a specified context of use). Investigate cognitive, physical, and situational contexts in which a product is used (systems thinking approach) and map in a workflow/task analysis. Create use scenarios and conduct usability risk management to capture potential use errors that are related to product usage and proposing UI mitigations to prevent the user from making the error. Create Usability engineering files (HFE report) to demonstrate that usability activities were successfully completed, and the product was found to be safe and effective. Defining, refining and substantiating product requirements for the design Scoping the work of the HFE team HFE's Reviewing the design Identifying and mitigating risks to the design; Overseeing your team HFE's to deliver a design that fulfils the BSC EP requirements within time and budget Support the Design Assurance Manager to enable a traceable, verifiable and validated design that is under Configuration Management Support the Risk Management Team to enable the preparation of the safety analysis and reports We are looking for a Lead Human Factors Engineer, located in the Boston area, who: Holds a Bachelor's or Master's degree in a relevant field to Human Factors Engineering Knowledge in both usability practice and design Vast Knowledge in the relevant medical usability official standards and guidelines Minimum of 10 years of relevant experience Experience in complex medical devices projects that includes both HW and SW Experience in Human Factors of high risk medical products (class 3) Excellent oral and written skills in English Can work accurately and has great organizational skills Self-reliant, assertive and knows how to paddle his/her own canoe - yet also greatly values and promotes teamwork; Solution-focused mindset; Can cope with stressful situations and has a flexible attitude; Team player who takes responsibility and can interface well with others Proactive in self-development (training, conferences) Have an understanding of quantitative and qualitative data and its analysis Participate in creating functional requirements, risk assessment, design reviews, verification & validation. Use of critical thinking to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems Ability and willingness to travel is required

Responsibilities

The Senior Manager of Human Factors and User Experience will develop and communicate a vision and strategy for Human Factors Engineering at EP, leading a team responsible for executing Human Factors within projects. This role involves collaborating with systems owners and designers to ensure the integration of Human Factors Engineering input into product design and managing usability evaluations throughout the product development process.