Medical Device Engineer II, Usability

Medical Device Engineer II, Usability

Responsible for planning and executing usability engineering activities for contact lens and lens care products in accordance with FDA, MDR, and other global regulatory requirements. Applies user-centered design and human factors principles, including analysis of device–user interfaces, rapid usability testing, and iterative design improvements based on user feedback. Contributes to safe and effective products by identifying and mitigating potential use errors across all aspects of the device experience, including packaging, labeling, and instructions for use.

Works closely with cross-functional internal teams to support usability and compliance objectives throughout the product development lifecycle.

• Perform usability assessments per IEC 62366 and other global and internal standards and procedures for new and existing products, including hazard identification, risk analysis, and applicable human factors analysis.
• Document effort required to support filings to regulatory bodies.
• Understand and assess user needs and motivations uncovered in research.
• Create experimental design concepts and prototypes.
• Conduct usability testing (planning, protocol development, data collection sheets, moderator scripts, material development, study coordination, IRB submissions, participant recruitment, study management, data collection, analysis, and documentation in technical reports).
• Analyze objective and subjective data from usability studies to inform design and provide alternative solutions. Present results to cross-functional teams with recommendations.
• Ensure product quality and that all tasks are in accordance with established SOPs, GMPs, Divisional Specifications, and EHS standards.
• Operate as an engineering lead on projects when needed.

• Bachelor’s Degree in Science or Engineering required;
  Bachelor’s degree in Human Factors Engineering or Biomedical Engineering preferred, and Interaction Design concepts helpful.
• 3+ years in Engineering, Process Development, Industrial Engineering, and/or Quality Engineering setting.
• Hands‑on experience and technical expertise in a development environment.
• Knowledge of usability engineering.
• Demonstrated track record of success in Human Factors engineering in a fast‑paced, collaborative environment.
• Strong skills in formative and summative test procedures and execution.
• Proficient technical writing required. Communication, organization, and presentation skills.
• Ability to work collaboratively with development teams, marketing, clinical, and medical affairs and effectively communicate research results and recommend next steps.
• Computer literacy with skills in Microsoft Excel, Word, Project, and PowerPoint.

• Knowledge of user-centered design and human factors, experience conducting risk analyses, quality management systems, GMP, medical device manufacturing experience.
• Experience with creating experimental design concepts and prototypes.

• Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date.
• 401K Plan with company match and ongoing company contribution.
• Paid time off – vacation (3 weeks – prorated upon hire), floating holidays and sick time.
• Employee Stock Purchase Plan with company match.
• Employee Incentive Bonus.
• Ongoing performance feedback and annual compensation review.

This position will be located in Rochester, NY.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.