Design Control & Risk Engineer - Contract

Job Title: Design Control & Risk Engineer
Location: Sunnyvale, CA 94086
Duration: 12+ Months

Primary Function of Position:
As part of the Client 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. For reference, a brief description of each of the business units is as follows.

Roles and 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 Intuitive laptop, software and administrative systems.

Qualifications
Skill/Job Requirements:
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 will consider for employment, qualified applicants with arrest and conviction records in accordance with fair chance laws.

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