Human Factors Engineer

Actalent; Burnsville (MN); On-site; USD 62,000 - 90,000; Full time

Benefits offered by this job

Medical insurance

Dental & Vision

401(k)

Disability insurance

Health Savings Account

Transportation benefits

Paid time off

Job summary

Actalent is seeking a mid-level Human Factors Engineer for a contract role in Burnsville, MN, supporting a medical device program with a software-based control room platform. The engineer will lead HFE activities, develop UI specs, and prepare FDA submissions.

The role requires 2-3+ years in HFE for medical devices, experience with formative and summative usability studies, and collaboration with cross-functional teams to deliver regulatory-ready documentation.

Qualifications

• 2-3+ years of Human Factors experience in medical devices.
• Experience supporting FDA-regulated products.
• Strong knowledge of Human Factors standards and safety regulations.
• Experience with use-related risk analysis and formative/summative studies.

Responsibilities

• Lead Human Factors Engineering activities for medical device development.
• Review, update, and create User Specifications and User Interface Specifications.
• Conduct Use-Related Risk Analyses and Formative Study Protocols.
• Prepare Human Factors documentation for FDA submissions.
• Plan, conduct, and document formative studies.
• Support and oversee summative validation activities.
• Conduct interviews with end users to capture user feedback effectively.
• Collaborate with cross-functional engineering teams to gather technical information and develop required protocols, plans, and reports.
• Support regulatory submissions by ensuring Human Factors deliverables meet FDA expectations.
• Act as the Human Factors subject matter expert for the project, leveraging existing work completed by an external consulting firm.

Skills

Mid-level HFE expertise

2-3+ years HFE

Medical device industry

FDA-regulated products

Use-related risk analysis

Job description

Job Title: Human Factors EngineerJob Description

We are seeking a mid-level Human Factors Engineer to support a medical device program involving a software-based control room platform. This platform supports catheter-based and transseptal needle procedures. With an established foundation in place, the organization is looking for an experienced professional to lead key Human Factors Engineering (HFE) activities internally.

Responsibilities

• Lead Human Factors Engineering activities for medical device development.
• Review, update, and create User Specifications and User Interface Specifications.
• Conduct Use-Related Risk Analyses and Formative Study Protocols.
• Prepare Human Factors documentation for FDA submissions.
• Plan, conduct, and document formative studies.
• Support and oversee summative validation activities.
• Conduct interviews with end users to capture user feedback effectively.
• Collaborate with cross-functional engineering teams to gather technical information and develop required protocols, plans, and reports.
• Support regulatory submissions by ensuring Human Factors deliverables meet FDA expectations.
• Act as the Human Factors subject matter expert for the project, leveraging existing work completed by an external consulting firm.

Essential Skills

• Mid-level Human Factors Engineering expertise.
• 2-3+ years of Human Factors experience, particularly in HFE.
• Medical device industry experience.
• Experience supporting FDA-regulated products.
• Strong understanding of Human Factors standards and safety regulations.
• Experience with IEC -1 and use-related risk analysis.
• Experience in conducting formative and summative usability studies and preparing regulatory documentation.

Additional Skills & Qualifications

• Experience in user research and end-user interviews.
• Proficiency in Human Factors validation planning and execution.
• Ability to collaborate cross-functionally with engineering teams.

Work Environment

The role involves working with high-tech medical equipment in an engineering environment. Collaboration with cross-functional teams will be essential, and a strong focus on meeting regulatory standards will be required.

Job Type & Location

This is a Contract position based out of Burnsville, MN.

Pay and Benefits

The pay range for this position is $45.00 - $65.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Burnsville,MN.

Application Deadline

This position is anticipated to close on Sep 23, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: 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.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.