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.***

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 Human Factors Design Controls Engineer on a contract basis to support our Customer's business needs. This role is 100% remote with domestic travel (up to 10%) to onsite locations.

The Human Factors Design Controls Engineer collaborates with cross-functional teams including Human Factors, Clinical Engineering, Interaction Design, Systems and Software Engineering, Product Management, Project Management, Technical Publications, Regulatory, and Quality.

This role is responsible for developing, guiding, and maintaining usability engineering documentation within Design Controls, ensuring compliance with medical device regulatory standards. The position provides subject matter expertise on design controls, content creation, and documentation management in tools such as Polarion and Agile, supporting submission readiness for global regulatory agencies.

This role serves as a key contributor to the Human Factors Engineering team across all business units and reports to a senior Human Factors leader.

Responsibilities:

• Plan and organize multiple product risk assessment remediation efforts running in parallel.
• Review and revise existing risk analysis documentation for remediation into updated formats aligned with current standards.
• Support Quality Engineering by collating, editing, and improving risk line items using standardized methodologies.
• Apply efficient document management practices to refine large volumes of technical content.
• Prioritize multiple document updates and manage competing timelines based on project needs.

Skills and Qualifications:

• Minimum of 5 years of relevant experience with a bachelor’s degree in engineering, human factors, or a related discipline.
• Professional experience in human factors engineering, clinical or product design engineering, quality engineering, design controls, risk management, or medical device development.
• Proficiency with design controls collaboration tools such as Polarion, Agile, or Smartsheet.
• Strong knowledge of medical device design control processes and QMS regulations (QSMR 13485).
• In-depth understanding of risk analysis principles and documentation per ISO 14971 and IEC 62366 standards.
• Excellent verbal and written communication skills with experience working across teams and management levels.
• Proficiency with multiple communication platforms (email, video conferencing, messaging tools).

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.