Senior Human Factors Engineer

Why you should join the BlackHägen Design Team

BlackHägen Design (BH), established three decades ago in Dunedin, FL, is a research and development company working with businesses from startups to Fortune 50 companies. At our core, user-centric processes drive innovative device development. As a result, most of our clients are medical device firms. Our culture is based on providing world-class services, balanced with living the coastal lifestyle enabled by a flex-time policy and remote work options. Moreover, as a consultant, the types of products and problems we solve change constantly, resulting in an inspirational and educational career path with highly satisfying accomplishments in the healthcare industry. At BH, we invest in you with opportunities through continuing education and professional development programs.

Job Description

The Senior HFE will work with the Director of Human Factors Engineering in a collaborative team environment as well as independently when needed, demonstrating individual initiative. This position will lead, participate in and/or support the Human Factors Engineering processes as a part of the overall medical product Design & Development Process. Activities include, but are not limited to, collecting and analyzing user research and use-related data, report on user-centric insights to develop design input documentation for user requirements, use-related risk analysis, evaluate medical devices, collaborate and engage with Design Engineering disciplines, both within BH and partner clients, and develop documentation for Regulatory submissions to FDA and international Regulatory entities. A strong understanding of user-research methodologies and Human Factors & Ergonomics Engineering principles is necessary to ensure work is completed in a rigorous, thorough and efficient manner.

Job Responsibilities

• Serve as a strategic leader and patient / user advocate while supporting BH clients in achieving their vision for delivering game-changing products that are safe & effective, easy to use, and not susceptible to use error
• Support and collaborate with Industrial Design (ID), User Experience Design (UXD), Mechanical Engineering (ME) and Software Engineering (SW) teammates and provide appropriate and accurate Human Factors & Ergonomic Engineering (HFE) inputs needed for usability-related requirements
• Lead and/or support HFE-related research activities including, but not limited to early Contextual Inquiry and Time/Motion research, Heuristic Analysis, and leading Formative and Summative usability evaluations/testing – moderating and notetaking skills are required
• Create and review HFE documentation, including, but not limited to, User & Use Environment Specifications, Task Analysis, Use-related Risk Analysis, Usability Engineering Plans, evaluation protocols with test methods to achieve client investigational goals, Human Factors Engineering reports for Formatives and Summative evaluations to support clients' Regulatory submissions
• Works on interdisciplinary teams with designers and engineers to analyze and evaluate data, conduct HF evaluations, and generate concept inputs, user interface requirements, and specifications
• Delivers accurate, well-defined, and articulate verbal and/or written presentations to clients as this role, at times, will be the main point of contact for BH clients
• Ability to learn, with relative quickness, a range of product interfaces from Drug Delivery Combination Products (DDCP) to Surgical-assisted Robotic Systems (SAR)
• Working knowledge of the implementation of all relevant HFE & usability-related Standards (ANSI/AAMI/ISO-14971, AAMI/ANSI: HE75, ANSI/AAMI/IEC-62366, IEC-60601, etc.) and FDA Guidance documents (Applying Human Factors and Usability Engineering to Medical Devices, etc.)

Education and Experience Requirements

• Experience leading and managing Human Factors Engineering and use/user research efforts including usability evaluation methodologies, recruitment, budgets, and project & personnel schedules
• Degree in Human Factors & Ergonomics Engineering, Usability Engineering, Cognitive Behavioral Psychology and/or Biomedical Engineering from an accredited school
• 4-7 years of work experience or a combination of education with demonstrated relevant work experience
• Experience practicing Human Factors/Usability Engineering in the Medical/Health Care domain is required
• Outstanding organization and time management skills
• Proficient in Microsoft 365 Suite (Outlook, Word, Excel and PowerPoint)
• Proficient in using video editing apps (e.g., Adobe Premiere Pro)

Benefits & Perks

• Flex time and remote working options
• Competitive salary commensurate with experience and qualifications
• 7 paid holidays
• Medical, dental, vision, AD&D and life insurance
• Health Savings Account contributions to subsidize insurance plan deductibles
• 2 weeks' vacation for the first four years and 3 weeks' vacation thereafter
• 40 hours of PTO, in addition to vacation
• Simple IRA investment plan matched up to 3% of salary per year
• Fitness membership (employee and spouse)

Must be legally authorized to work in the United States

We are a FL Drug Free Workplace, all candidates must be able to pass a criminal background & drug check.

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Job Type: Full-time

Pay: $105, $130,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Flexible schedule
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance
• Vision insurance

Work Location: Remote