Boston Scientific
Human Factors Engineering Lead - Electrophysiology
Boston Scientific, Waltham, Massachusetts, United States, 02451
Human Factors Engineering Lead - Electrophysiology
At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information, and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing
whatever your ambitions. As our Lead in Human Factors Engineering (HFE), you will be responsible for managing the implementation of a full scope Human Factors Engineering program in the EP division. This involves owning the strategy and vision for the HFE team, growing a team to support this strategy, mentoring reports in the application of HFE best practices, and applying HFE principles across various aspects of multiple projects. You will report to the Director of System Engineering and will work in close collaboration with the Systems Engineering, Product Development, and Marketing teams. As part of the global EP R&D team, your challenge will be to contribute to the creation of safe, and easy to use solutions with an outstanding experience for a broad range of medical devices that EP brings to market. Job Duties and Activities: 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 Human Factors Engineering analyses: Task and user analysis, Usability plan Use scenarios Use Related Risk Analysis Usability requirements Formative and summative evaluations (plan, execute, analyze, report) Usability Engineering File Verification and validation with respect to Human Factors (including design validation and integrated systems validation) 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 Aligning the Human Factors Engineering process with engineering processes such as Systems Engineering and SW & HW teams Fulfil a Design Authority role, meaning you will be responsible for the acceptance of HFE information prepared by (overall) responsible designers, assessing changes to the design and ensuring Knowledge Management of the design within your scope Are the owner of HFE, meaning that you are responsible for: 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 Your role: 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 methodsreporting 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. Requirements/Your profile: 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 You believe advice means questioning, thinking critically, planning and acting. You are a good listener, with a high degree of empathy for different stakeholders, and you have a hands-on mentality to get things done. You're confident enough to challenge and advise against things that you feel won't work, backed by your expertise in Human Factors Engineering.
At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information, and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing
whatever your ambitions. As our Lead in Human Factors Engineering (HFE), you will be responsible for managing the implementation of a full scope Human Factors Engineering program in the EP division. This involves owning the strategy and vision for the HFE team, growing a team to support this strategy, mentoring reports in the application of HFE best practices, and applying HFE principles across various aspects of multiple projects. You will report to the Director of System Engineering and will work in close collaboration with the Systems Engineering, Product Development, and Marketing teams. As part of the global EP R&D team, your challenge will be to contribute to the creation of safe, and easy to use solutions with an outstanding experience for a broad range of medical devices that EP brings to market. Job Duties and Activities: 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 Human Factors Engineering analyses: Task and user analysis, Usability plan Use scenarios Use Related Risk Analysis Usability requirements Formative and summative evaluations (plan, execute, analyze, report) Usability Engineering File Verification and validation with respect to Human Factors (including design validation and integrated systems validation) 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 Aligning the Human Factors Engineering process with engineering processes such as Systems Engineering and SW & HW teams Fulfil a Design Authority role, meaning you will be responsible for the acceptance of HFE information prepared by (overall) responsible designers, assessing changes to the design and ensuring Knowledge Management of the design within your scope Are the owner of HFE, meaning that you are responsible for: 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 Your role: 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 methodsreporting 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. Requirements/Your profile: 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 You believe advice means questioning, thinking critically, planning and acting. You are a good listener, with a high degree of empathy for different stakeholders, and you have a hands-on mentality to get things done. You're confident enough to challenge and advise against things that you feel won't work, backed by your expertise in Human Factors Engineering.