UI/Human Factors Engineer 3 - Human Factors Design Controls Engineer

***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 remote.

Role Overview:

• As part of the Human Factors team, the Human Factors Design Controls Engineer works closely with fellow HF team members and department leadership and other cross functional partners.
• The Human Factors Design Controls Engineer is a key contributor to inform, guide development of, and maintain usability engineering documentation produced during product development projects.
• Responsibilities are focused on 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 content creation in tools such as Polarion and document control software (Agile) 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 of usability related risk analysis documentation, including revising, editing and reformatting, collating and tracing of task analysis and usability risk analysis document content.
• Support definition, release and maintenance of usability related design inputs documentation.
• Create and maintain tracing documentation with the Polarion tracing environment to Identify and resolve tracing conflicts and design input orphans in tracing between risks and design inputs/risk controls.
• This position is remote, using the company's laptop, software and administrative systems.

Qualifications:

• Minimum Education: BS in Human Factors Engineering, Biomedical Science or Engineering, Systems Engineering, Quality Engineering, Information and Data Science, Cognitive Psychology, Computer Science with human-computer interface (HCI) emphasis, Human Centered Design, or related field.
• Minimum of 5 years of related experience with a bachelor’s degree in engineering, and have experience design controls, risk remediation, and risk analysis related medical device product development (or related field).
• Experience working with Digital project collaboration tools is required. (e.g. Polarion, Agile, Smartsheets etc.).
• Background and understanding of MDR regulations and best practices for medical device human factors (e.g. IEC 62366, AAMI HE75, FDA Applying Human Factors and Usability Engineering to Medical Devices).
• Excellent verbal communication and presentation skills working within a highly statured communication environment using multiple communication channels (email, text, video conference, instant messaging platforms).

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.