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Human Factors Engineer Medical Device Jobs in Wisconsin

Kellton Tech

Medical Device Assembler

Madison, WI · On-site

$23 - $24/hr

Job Title: Medical Device Assembler Location: Madison, WI (Onsite) Pay Rate: $23-24/hr on W2 ... Engineering group as required. Working Conditions: Clean, temperature controlled environment.

Haemonetics Software Solutions

WI · On-site

$51 - $87/hr

... Engineer (FSE) will support the Blood Management Centers and Hospitals onsite in the field and provide ongoing customer support. This position is responsible for providing device installation ...

Experis

Medical Device Test Engineer

Waukesha, WI · On-site

As a Medical Device Test Engineer, you will be part of the Quality Assurance department supporting ... Guided by the belief that it takes Human Ingenuity to unlock the true potential of technology ...

HonorVet Technologies

Medical Device Technician

Madison, WI · On-site

$38K - $48K/yr

Medical Device Technician Location: Madison, WI 53718 Duration: 6+ months of contract with ... Bachelor's degree in engineering or related scientific field. Associate's degree with 2+ years ...

Kellton Tech

Medical Device Technician

Madison, WI · On-site

$38K - $48K/yr

Medical Device Technician Location: Madison, WI (Onsite) Scope of Work: Assemble and test medical ... Bachelor's degree in engineering or related scientific field. Associate's degree with 2+ years ...

Baxter Healthcare

WI · On-site

$96 - $132/hr

... medical device interfaces and digital health solutions. Located in Round Lake, this role is ... Partner with Human Factors Engineering to integrate IEC 62366 and FDA usability requirements into ...

Kellton Tech

Medical Device Quality Engineer

Madison, WI · On-site

$40 - $45/hr

Medical Device Quality Engineer Location: Madison, WI Pay Rate : $40--45/hr on W2 Schedule: Onsite, Monday-Friday (standard business hours) Summary The Senior Quality Analyst/Engineer is responsible ...

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All JobsHuman Factors Engineer Medical Device JobsHuman Factors Engineer Medical Device Jobs in Wisconsin

Human Factors Engineer Medical Device information

What is a human factors engineer in the medical device industry?

A Human Factors Engineer in the medical device industry is responsible for ensuring that medical devices are safe, effective, and easy to use by considering how people interact with technology. They apply principles of human psychology, engineering, and design to optimize device usability and minimize user errors. Their work often includes conducting usability testing, analyzing user feedback, and collaborating with product development teams to ensure regulatory compliance and improve patient outcomes.

How do human factors engineers collaborate with regulatory teams during the development of medical devices?

Human Factors Engineers frequently work alongside regulatory teams to ensure that medical devices meet stringent usability and safety requirements set by agencies like the FDA. This collaboration involves documenting user research, risk analyses, and validation studies to support regulatory submissions. Regular communication helps align design decisions with compliance standards, ensuring that the device is both user-friendly and legally marketable. As a result, Human Factors Engineers play a critical role in guiding the product through the approval process.

What are the key skills and qualifications needed to thrive as a human factors engineer in medical devices, and why are they important?

To excel as a Human Factors Engineer in Medical Devices, you need a solid background in human factors engineering, usability testing, and regulatory knowledge, typically supported by a degree in engineering, psychology, or a related field. Familiarity with tools like usability testing software, prototyping platforms, and standards such as IEC 62366 is important, along with experience in documentation for FDA submissions. Strong analytical thinking, communication, and collaboration skills help in translating user needs into safe, effective device designs. These competencies ensure medical devices are user-friendly, compliant, and minimize risks to patient safety.

What is the difference between Human Factors Engineer Medical Device vs Human Factors Specialist Medical Device?

AspectHuman Factors Engineer Medical DeviceHuman Factors Specialist Medical Device
CredentialsBachelor's or Master's in Human Factors, Psychology, or Engineering; certifications like HF/E certificationSimilar credentials, often with additional certifications in usability or ergonomics
Work EnvironmentDesign teams in medical device companies, R&D labs, regulatory environmentsUsability testing labs, clinical settings, regulatory agencies
Industry UsageDesign and optimize medical devices for usability and safetyConduct usability assessments, risk analysis, and compliance documentation

While both roles focus on usability and safety in medical devices, Human Factors Engineers typically lead design and development, whereas Human Factors Specialists often focus on usability testing and compliance. Both roles require similar credentials and work within the same industry environment, but their specific responsibilities differ slightly.

Are human factors engineers in demand?

Human factors engineers in medical devices are in high demand due to increasing focus on user safety, device usability, and regulatory compliance. They often work in healthcare, technology, and manufacturing sectors, utilizing skills in ergonomics, usability testing, and regulatory standards like FDA guidelines.

How much does a human factors engineer medical device make?

A human factors engineer in the medical device industry typically earns between $80,000 and $130,000 annually, depending on experience, education, and location. Senior roles or those with specialized skills in usability testing and regulatory standards can earn higher salaries, often exceeding $150,000.

What are popular job titles related to Human Factors Engineer Medical Device jobs in Wisconsin?

For Human Factors Engineer Medical Device jobs in Wisconsin, the most frequently searched job titles are:

What job categories do people searching Human Factors Engineer Medical Device jobs in Wisconsin look for?

The top searched job categories for Human Factors Engineer Medical Device jobs in Wisconsin are:

What cities in Wisconsin are hiring for Human Factors Engineer Medical Device jobs?

Cities in Wisconsin with the most Human Factors Engineer Medical Device job openings:

Human Factors Engineer Medical Device jobs near you
Infographic showing various Human Factors Engineer Medical Device job openings in Wisconsin as of July 2026, with employment types broken down into 77% Full Time, 15% Part Time, and 8% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution.

Engineer, Device Engineering

Scorpion Therapeutics

Madison, WI • On-site

$120 - $145/hr

Other

Posted 5 days ago

Job description

Responsibilities:
  • Develop and execute strategies/roadmaps for drug-device combination product programs.
  • Provide technical leadership from concept through commercialization and lifecycle management.
  • Lead human factors/usability engineering; author/review plans, URRAs, protocols, reports, and design control documentation.
  • Lead formative/summative human factors evaluations and interpret results.
  • Provide technical expertise in drug delivery technologies, device/system engineering, design controls, risk management, materials, and manufacturing processes.
  • Lead development of prefilled syringes, autoinjectors, and other drug delivery systems.
  • Collaborate cross-functionally (Product Development, Packaging, Manufacturing, Clinical, Supply Chain, Commercial, Quality, Regulatory).
  • Oversee external testing labs; establish/maintain design control processes and DHF documentation.
  • Support design transfer (risk assessments, specs, control strategies, statistical evaluation).
  • Author/review combination-product regulatory submission sections (IND/IMPD/BLA/MAA).
  • Ensure compliance with FDA/EU requirements and standards (ISO 14971, ISO 13485, EU MDR); manage risks and vendors.
Requirements:
  • BS in Biomedical/Mechanical Engineering, Pharmaceutical Sciences, or related.
  • 8+ years in combination product/medical device development; concept-to-commercialization/lifecycle.
  • Experience commercializing prefilled syringes and autoinjectors.
  • Knowledge of subcutaneous delivery systems, device design, systems engineering, materials, manufacturing.
  • Experience with design controls, risk management, human factors/usability engineering.
  • Knowledge of FDA/EU regulations/quality systems (ISO 14971, ISO 13485, EU MDR).
  • Experience with device characterization/design verification testing and device regulatory submission content.
  • Strong communication, cross-functional influence, and project management.
Preferred:
  • Advanced degree.
  • Experience with biological drug products/primary packaging.
  • cGMP process development, manufacturing controls, process risk assessments, design transfer.
  • Fast-paced biotech/pharma experience; mentoring/technical leadership.
Compensation/Benefits:
  • Wisconsin pay range: $120,000–$145,000; California pay range: $135,000–$155,000.
  • Competitive salaries and an excellent benefit package.
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