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Sr. Human Factors/Usability Engineer at Candela Medical


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Role Description:
Company Profile

Candela is recognized globally for its innovative energy-based technologies that change lives. Our new brand embodies our continued commitment to innovating medical aesthetic treatment solutions based on solid science and effective outcomes. We aspire to provide the highest levels of clinical, technical, and customer support and continue to build on the longstanding partnerships of trust we’ve established with physicians, their practices, and the patients they treat.

General Summary

The Sr. Human Factors/Usability Engineer is a key subject matter expert within the Systems Engineering function that is involved with all aspects of application of usability engineering across Candela’s aesthetic product line. This responsibility includes applying User-Centered Design Thinking on projects throughout Candela’s product development process.

Essential Job Functions

Act as Human Factors Engineering/Usability single point of contact (SPOC) and subject matter expert (SME) on human factors engineering topics
Collaborate with cross-functional team on product definition activities including Stakeholder Analysis, User Needs Elicitation, VOC Translation, Concept Development, and Product Requirements Definition
Collaborate with industrial designers to develop product concepts, lead concept evaluation and selection activities, and translate preferences to multi-disciplinary design team for implementation
Lead creation of User Experience (UX) design documentation, such as Use and User Interface Specifications, in collaboration with cross-functional team, including Service and Manufacturing
Lead task analyses and use-related risk analyses, in close collaboration with DQA
Collaborate with Clinical Affairs to develop instructions for use and other training materials
Lead human factors research activities, including planning, execution, analysis, and reporting. Manage third-party partners, as needed.
Author regulatory documentation, including human factors summary reports
Provide system design support by working closely with global-system architects to develop and maintain system design documentation (i.e. system block diagrams, interface control documentation, system models, etc.)
Support system design documentation utilizing tools, attend design reviews as an independent reviewer, participate in system design workshops and review system design documentation/deliverables for NPI projects.
Support the Engineering Change Process (ECO) for use-related design related changes where these and associated documents may be subject to change.
Provide leadership in the areas of human factors engineering to support continuous improvement and education/training.
Work closely with RA/QA/DQA functions to ensure cross team alignment to changes and international standards landscape as well as changes to internal standards and procedures, providing the system engineering team with periodic updates and establishing/maintaining gap-analysis.
Work closely with management to ensure proper planning and training in this space.
Provide general support of system validation related sustaining activities such as CAPA’s, CAR’s etc.
Lead through engagement, collaboration and indirect influence of cross-functional resources to obtain consensus, while connecting with people empathetically, energizing and motivating your teammates, and inspiring them to work toward the project goals.
Work closely with Product Qualification (V&V) leads to establish system verification & validation strategy, manage and lead defect resolution, trace matrix, and support design transfer.
Maintain compliance with design controls, program documentation including internal phase review discipline, site quality and regulatory system.
Interface broadly across project and global engineering teams; cross functionally with Quality/Regulatory, Service, Manufacturing, Sourcing, Project Management, and Marketing; and with various external development teams.
Maintain open communications with company leadership and ongoing engagement of line management in project activities.
Review and critique documentation and presentations for others; present complex technical data to large and diverse groups.
Establish and maintain good understanding of clients, industry, and commercial markets.

Knowledge/Educational Requirements

BS or MS (preferred) in Human Factors Engineering, Usability Engineering, Ergonomics, Psychology, Biomedical or Systems Engineering
Minimum of 5 years direct experience in human factors or usability engineering in complex medical devices or other safety-critical industry
Working knowledge of FDA, EU, IEC and AAMI standards relating to usability engineering for medical devices (e.g. AAMI/ANSI HE75, IEC 62366, ISO 14971, ISO 13485, FDQ QSR, EUMDR, etc)
Familiarity with research techniques, including field research, usability testing, ergonomic assessment, and expert review
Demonstrated track record of planning, executing, moderating, and reporting usability studies, including formative and summative studies
Experience creating usability file deliverables including user needs, use-related risk assessment, research protocols and reports, and HF summary reports
Excellent interpersonal, organizational as well as verbal and written communication skills
Proficiency with Microsoft Windows Office tools
Good level familiarity with MS Project and/or Smartsheet
This job description is not all inclusive and is intended to capture a majority of the job functions. Special projects and other tasks may be required by management.

Candela Corporation is proud to be an Equal Employment Opportunity and Affirmative Action Employer and is committed to creating a diverse and inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

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Candela Medical
251 Locke Drive, Marlborough, MA 01752

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