Principal Usability and Human Factors Engineer

5 days ago

Valhalla, United States PEAK Technical Staffing Full time

HYBRID ROLE - VALHALLA, NY// to // Regulatory Support team in crafting responses to questions from regulators about on ongoing submission Document usability validation for planned submissions Labeling/IFU Development Work with Packaging Engineering team to develop updates to content and format of labeling and IFU assets Test proposed labeling designs for usability and readability Plan and execute (with help of outside agency) summative usability testing to validate packaging design changes Review and update Usability Evaluation Procedure Preferred qualifications: Systems thinker/thought leader able to lead cross-functional discussions Experience designing and leading usability evaluation and validation Experience with medical devices and/or IVD devices a plus Expected responsibilities include working with cross-functional teams and outside agencies to design, execute, and document usability studies. Candidate will also support ongoing and planned regulatory submissions with respect to usability validation. Responsibilities include: Regulatory Support Support team in crafting responses to questions from regulators about on ongoing submission Document usability validation for planned submissions Labeling/IFU Development Work with Packaging Engineering team to develop updates to content and format of labeling and IFU assets Test proposed labeling designs for usability and readability Plan and execute (with help of outside agency) summative usability testing to validate packaging design changes Review and update Usability Evaluation Procedure Preferred qualifications: Systems thinker/thought leader able to lead cross-functional discussions Experience designing and leading usability evaluation and validation Experience with medical devices and/or IVD devices a plus Benefits PEAK's benefit offerings available for our associates include medical, dental, vision, Flexible Spending Account (FSA), Dependent Care Savings Account (DCA), and K plan. PEAK believes that taking care of our team is essential for success and we are proud to provide benefits that enhance both your well-being and your future. Additionally, our associates may be eligible for Paid Sick Leave as required by Federal, State, or local laws. Equal Opportunity Employer (EEO)  PEAK Technical Staffing is committed to creating a diverse and inclusive environment and is proud to be an Equal Opportunity Employer. PEAK does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status, or any other characteristic protected by applicable law. All employment decisions are made based on qualifications, merit, and business need. We encourage all individuals to apply.  Candidate Privacy To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to and AI Recruiting Disclosure  We use AI-assisted tools to help review applications and compare your experience to job requirements, but all hiring decisions are made by human recruiters. You may request a human-only process or opt out of automated communication at any time. Required notices and our latest bias audit are available on our website: .

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