Senior Human Factors Design Controls Engineer (100% Remote)

***Please note that our customer is currently not considering applicants from the following locations: Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, and Tennessee.***

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Our Customer is a corporation that develops, manufactures, and markets robotic products designed to improve clinical outcomes of patients through minimally invasive surgery. Founded in 1995, their goal was to create innovative, robotic-assisted systems that help empower doctors and hospitals to make surgery less invasive than an open approach. Working with the top medical professionals, they continue to develop new, minimally invasive surgical platforms and future diagnostic tools to help solve complex healthcare challenges around the world.

We are seeking a Senior Human Factors Design Controls Engineer on a contract basis to support our Customer's business needs. This role is 100% remote with 15% travel to onsite locations.

The Sr. Human Factors Design Controls Engineer works closely with human factors team members, department leadership, clinical engineers, interaction designers, system and software engineers, product managers, project management, technical publications, regulatory, and quality teams. This role is a key contributor to the development and maintenance of usability engineering documentation within design controls, supporting submissions to global medical device regulatory agencies.

Responsibilities include implementing usability engineering deliverables such as known use problem reports, task analyses, risk analyses, design inputs, and usability validation test cases. The role also provides expertise in design controls and documentation using tools such as Polarion and Agile, while ensuring best practices in compliance with regulatory standards.

Responsibilities:

Research

• Support the definition, release, and maintenance of task analyses and comparative task analyses documentation.
• Generate and maintain known use problem documentation (e.g., quality data review documentation).
• Support the definition and release of usability engineering plans.

Design

• Support the definition, release, and maintenance of usability-related risk documentation.
• Support definition, release, and maintenance of usability-related design inputs.
• Create and maintain tracing documentation.

Test

• Guide human factors teams on best practices for defining validation test cases.
• Support proper tracing between task analyses, risks, design inputs, and test cases.

Analyze

• Identify and resolve tracing conflicts and design input orphans between risks and risk controls.
• Analyze complaints from on-market products, update usability risk assessments, and escalate usability-related issues when necessary.

Sustain and Improve

• Stay current on MDR regulations and best practices (e.g., IEC 62366, AAMI HE75, FDA guidance).
• Recommend process improvements related to usability engineering and design controls.
• Contribute to the continuous improvement of usability engineering processes and practices.

Collaborate

• Lead efforts to create and update usability risk analyses.
• Represent the Human Factors Design Controls function on project core teams.
• Coordinate human factors efforts across multi-subsystem projects.
• Mentor junior engineers and colleagues in design control methods, best practices, and product development processes.

Skills and Qualifications

• Bachelor’s degree in Human Factors Engineering, Biomedical Science or Engineering, Systems Engineering, Quality Engineering, Information/Data Science, Cognitive Psychology, Human-Computer Interaction, Human-Centered Design, or related field.
• Minimum of 8 years of related experience in engineering, design controls, or medical device product development.
• Strong verbal communication and presentation skills across multiple communication platforms (email, video, instant messaging, etc.).
• Experience with digital project collaboration tools (e.g., Polarion, Agile, Python, Smartsheet).
• Ability to collaborate across functions, including engineering, marketing, clinical engineering, and regulatory, to solve complex usability issues.
• Knowledge of medical device usability regulations and standards (IEC 62366, AAMI HE75, FDA guidance).
• Ability to travel domestically and internationally up to 15%.

We offer a competitive salary range for this position. Most candidates who join our team are hired at the median of this range, ensuring fair and equitable compensation based on experience and qualifications.

Contractor benefits are available through our 3rd Party Employer of Record (Available upon completion of waiting period for eligible engagements) Benefits include: Medical, Dental, Vision, 401k.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.