Remote Polarion Jobs (NOW HIRING)

Summary:

As part of the Client Human Factors team, The Human Factors Design Controls Engineer works closely with fellow HF team members and department leadership, as well as collaborates with, clinical engineers, interaction designers, system and software engineers, product managers, project management and technical publications, in addition to regulatory and quality. The Human Factors Design Controls Engineer is a key contributor to inform, guide development of, and maintain usability engineering documentation produced during projects within Design Controls. This role supports the Human Factors Engineering team with expertise in design controls and content creation in tools such as Polarion and Agile, and helps to create the 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 Sr. Human Factors staff member.

Roles and Responsibilities:

Assist in planning and organization for multiple product risk assessment document remediation efforts running in parallel for a set grouping of risk analysis documents
Analyze existing risk analysis documents for remediation into new risk assessment document formats, including editing and revising risks per Intuitive risk management process and standards.
Support Quality Engineering in collating, editing and improving large amounts of risk line items using efficient methods within a standardized methodology for document remediation.
Assess and prioritize plans for working on multiple documents in parallel, according to emergent needs of document content that may require mode or less effort to refine and improve content.
Skill/Job Requirements:
Minimum of 5 years of related experience with a bachelor's degree
Relevant work experience in human factors engineering, clinical engineering, product design engineering, quality engineering, design controls, risk management and medical device product development.
Strong experience working with design controls project collaboration tools is required. (e.g. Polarion, Agile, Smartsheets etc.).
Knowledge and experience working within medical device design controls process and documentation methodologies, compliant with medical device quality management system regulation (QSMR 13485)
Demonstrable knowledge in medical device risk analysis principles and practices, and risk analysis documentation according to ISO14971 and 62366.
Ability to collaborate with and across various groups and levels of management within the organization.
Strong verbal communication and data analysis skills working within a highly statured communication environment using multiple communication channels (email, text, video conference, instant messaging platforms).
Ability to travel domestically (up to 10%) to onsite locations if remote.

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