Sr. Human Factors Design Engineer - Medical Devices

A leading medical technology organization is seeking a Senior Human Factors Design Engineer (Direct Hire) to help shape the safety, usability, and overall user experience of next-generation medical devices and complex electromechanical products.

• Lead Human Factors & Usability Engineering: Own usability engineering activities for complex product development programs, including user research, task analysis, usability requirements, use-related risk analysis, formative evaluations, and formal validation studies.

• Drive Human-Centered Product Design: Translate observations, interviews, simulations, usability findings, and customer feedback into actionable design recommendations that reduce use errors and improve product safety and usability.

• Manage Usability Risk & Regulatory Documentation: Develop and maintain usability risk assessments, traceability between risks and mitigations, validation strategies, test protocols, reports, and Human Factors documentation supporting medical device regulatory submissions.

• Provide Technical Leadership: Represent Human Factors on cross-functional product teams, coordinate usability activities across multiple systems and projects, communicate schedules and findings to stakeholders, and mentor engineers in Human Factors methods and industry best practices.

• Education: Bachelor's degree in Human Factors Engineering, Cognitive Psychology, Human-Computer Interaction (HCI), Human-Centered Design, Computer Science with an HCI focus, or a related discipline; master's degree strongly preferred.

• Experience: 8+ years of relevant Human Factors, usability engineering, or user-centered product development experience involving hardware products; experience with medical devices or another highly regulated industry is strongly preferred.

• Technical Expertise: Demonstrated ability to independently lead usability engineering for complex software-controlled electromechanical products, including usability requirements, use-related risk analysis, formative and validation testing, protocols, data analysis, and technical reports.

• Regulatory & Communication
  
  Skills:
  
  Strong knowledge of medical device Human Factors principles and applicable guidance/standards such as IEC 62366, AAMI HE75, and FDA Human Factors/Usability Engineering guidance
  , combined with excellent technical writing, presentation, customer-facing, and cross-functional collaboration skills.

Location: Sunnyvale, CA - Onsite M-F
** Relocation Assistance Available **

Travel: up to 25%

Salary: 170-245K (DOE) + 15% bonus

Benefits: Medical, Dental, Vison, HSA, FSA, Critical Illness Ins, Accident Ins, Hospital Indemnity Ins, Accolade Care, STD, LTD, California Disabilty Ins., Basic Life & Accidental Death, Supplemental life and accidental death, 401K match 200% on the first $1K. PTO 3 weeks

Pay Details: $ to $ per year

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Equal Opportunity Employer/Veterans/Disabled

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance