Human Factors Design Controls Engineer (Remote - PST Shift)

***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, PST shift.

The Human Factors Design Controls Engineer is a key contributor to inform, guide the development of, and maintain usability engineering documentation produced during product development projects. Responsibilities are focused on the comprehensive and timely implementation of task analysis and related risk analysis documents.

This role supports the Human Factors Engineering team with expertise in design controls and helps create usability engineering documentation required for submission to global medical device regulatory agencies.

This role provides dedicated support and subject matter expertise guidance to the broader human factors engineering team serving all business units, and reports to a Human Factors team lead.

Responsibilities:

• Support remediation activities related to usability risk analysis documentation.
• Revise, edit, reformat, collate, and trace task analysis and usability risk analysis documentation.
• Support the definition, release, and maintenance of usability-related design input documentation.
• Create and maintain traceability documentation within the Polarion tracing environment.
• Identify and resolve tracing conflicts and design input orphans between risks, design inputs, and risk controls.
• Support design controls, risk remediation, and risk analysis activities within medical device product development processes.
• Collaborate with cross-functional teams using digital project collaboration tools and administrative systems.
• Maintain documentation accuracy, consistency, and compliance with medical device usability and risk management standards.
• Support remote collaboration using company-provided systems, tools, and communication platforms.

Skills and Qualifications:

• Bachelor’s degree in Human Factors Engineering, Biomedical Science, Biomedical Engineering, Systems Engineering, Quality Engineering, Information and Data Science, Cognitive Psychology, Computer Science with HCI emphasis, Human-Centered Design, or related field.
• Minimum of 5 years of related experience in engineering, medical device development, or related industries.
• Experience with design controls, risk remediation, and risk analysis within medical device product development.
• Experience using digital collaboration and project management tools such as Polarion, Agile PDM, Smartsheet, or similar platforms.
• Strong understanding of MDR regulations and medical device human factors best practices.
• Familiarity with standards and guidance, including IEC 62366, AAMI HE75, and FDA Human Factors and Usability Engineering guidance for medical devices.
• Strong documentation, editing, and traceability management skills.
• Ability to identify and resolve traceability conflicts and documentation gaps.
• Strong analytical and problem-solving skills.
• Excellent verbal and written communication skills.
• Experience working within highly structured communication environments using email, messaging platforms, and video conferencing tools.
• Ability to work independently within remote environments while managing multiple priorities.

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.