Sr. Human Factors Design Engineer - Medical Devices

Lee Hecht Harrison
  • Sunnyvale, CA
  • $170,000–$245,000 Per Year
12 days ago

Job Description

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.

Key Responsibilities

  • 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.

Qualifications

  • 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

APPLY NOW!!

"Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.lhh.com/us/en/candidate-privacy

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

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

Pay Details: $170,000.00 to $245,000.00 per year

Search managed by: Deanna Murphy

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.lhh.com/us/en/candidate-privacy

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

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

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.

Numbers & Facts

LocationSunnyvale, CA
Salary$170,000–$245,000 Per Year

Skills

  • Association for the Advancement of Medical Instrumentation (AAMI)unmatched
  • Best Practicesunmatched
  • Cognitive Psychologyunmatched
  • Communication Skillsunmatched
  • Computer Scienceunmatched
  • Cross-Functionalunmatched
  • Customer Relationsunmatched
  • Customer/Client Researchunmatched
  • Data Analysisunmatched
  • Documentationunmatched
  • Electromechanicsunmatched
  • FDA (Food and Drug Administration)unmatched
  • Human Factorsunmatched
  • Human-Computer Interactionunmatched
  • International Electro-Technical Commission (IEC)unmatched
  • Leadershipunmatched
  • Medical Equipmentunmatched
  • Medical Organizationsunmatched
  • Mentoringunmatched
  • Product Designunmatched
  • Product Developmentunmatched
  • Product Safetyunmatched
  • Project Scheduleunmatched
  • Protocol Analysisunmatched
  • Regulationsunmatched
  • Regulatory Submissionsunmatched
  • Requirements Managementunmatched
  • Risk Analysisunmatched
  • Risk Managementunmatched
  • Software Engineeringunmatched
  • Support Documentationunmatched
  • Team Playerunmatched
  • Technical Leadershipunmatched
  • Technical Presentationunmatched
  • Technical Writingunmatched
  • Technical/Engineering Designunmatched
  • Test Strategyunmatched
  • Traceabilityunmatched
  • Usability Engineeringunmatched
  • User Interface/Experience (UI/UX)unmatched
  • Validation Planunmatched
  • Validation Testingunmatched
  • Willing to Travelunmatched
  • Writing Skillsunmatched

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