Senior Usability Engineer (MedTech)

TL;DR

Senior Usability Engineer (MedTech): Leading human factors and usability engineering for new product development and enhancements in the resuscitation division with an accent on user research, hazard analysis, and regulatory compliance. Focus on executing formative and summative studies, authoring design history files, and ensuring adherence to FDA and IEC standards.

Location: Chelmsford, MA. ZOLL does not provide immigration-related sponsorship for this role.

Salary: $110,000 – $140,000

Company

A medical technology company developing innovative lifesaving products for EMS, hospital, and military customers worldwide.

What you will do

• Lead usability efforts across multiple programs, managing planning and execution of deliverables with minimal supervision.
• Author essential design history file documentation, including usability plans, task analysis, use error analysis, and usability engineering files.
• Develop test protocols and coordinate with external research facilities to recruit participants and manage testing.
• Conduct root-cause analysis of test results and perform MAUDE searches to identify known use problems.
• Collaborate with cross-functional development teams to identify and mitigate use-related hazards early in the design process.
• Mentor junior usability team members and perform peer reviews of technical documentation.

Requirements

• BS or MS in Human Factors Engineering, Biomedical Engineering, or a related engineering discipline.
• 5+ years of work experience, with at least 4 years specifically in Usability Engineering for medical devices.
• Practical experience applying IEC 62366, 60601-1-6, FDA Guidance, and MDR to medical device development.
• Must not require immigration sponsorship (e.g., H1B, TN, STEM, OPT) now or in the future.
• Strong communication and writing skills for interacting with customers and stakeholders.

Nice to have

• Experience developing prototypes using software simulation tools.

Culture & Benefits

• Impactful work contributing to saving lives across 140+ countries.
• Culture that values innovation, self-motivation, and an entrepreneurial spirit.
• Eligible for an annual bonus according to the company's bonus plan.
• Comprehensive corporate benefits package.