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Principal Human Factors Engineer, Medical Device


Lake Forest, IL
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Job Details

Job Title Principal Human Factors Engineer, Medical Device

JobID 1046589-1852

Location: Lake Forest, IL

Description *About Pfizer*

A career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

*Role Description*

Hospira, a Pfizer company, is the global leader of injectable drugs and infusion technologies, committed to putting patients first by improving access and care worldwide. THE ROLE:The primary responsibility for Principal Human Factors Engineer is to ensure that assigned devices, associated labelling and packaging, and training (if applicable) are designed to be safe and effective for use by intended users within intended environments for all chosen markets. As part of the Pfizer product development teams, this role will be accountable to work with external design companies and human factors vendors in developing and ensuring timely execution of human factors engineering deliverables for assigned devices.


*Generate and ensure approval of all Pfizer device human factors engineering documentation for assigned projects*Perform task analysis and use error assessment to identify critical and essential tasks. Provide input into risk management activities for assigned projects ensuring risk files are aligned with human factors activity and feedback*Provide device usability input/support to device design inputs and device design specification*Generate Human Factors and Design Validation objectives and deliverables plan, and document goals and strategies within a Design Validation and HF plan*Manage all human factors (HF) activities associated with HF vendors, including on boarding of HF vendor, generation of study brief, attainment of HF vendor proposals, assignment of HF vendor, providing all relevant materials and documentation, management of HF studies, and generation and approval of associated reports*Project manage the supply, assembly and testing of materials for use in HF studies and associated documentation*Report any adverse findings or adverse events witnessed at HF studies and ensure appropriate action*Ensure timely execution of HF studies for assigned projects*Provide HF study feedback and/or recommended mitigation actions into the project Core Team*Provide input and support for generation of assigned Pfizer device Instructions for Use (IFU), device labelling and packaging*Design and ensure full change control for IFU documentation where applicable for assigned projects*Support the generation of device regulatory submission data. Ensure high quality deliverables in compliance with Regulation and local procedures.*Assist in the application of HF engineering principles and controls for all device development projects*Support and conduct human factors research to augment present and future device projects including in-house laboratory testing and external research with the support of contract staff/vendors*Support internal and external audits of HF related aspects of the Quality System


Bachelor's Degree in human factors engineering, experimental psychology, cognitive psychology, industrial design or a related field with 10 years of relevant exp; OR Master's degree in one of the above fields from an accredited university and a minimum of 6 years of relevant industry experience.Required: Understanding of FDA and EU regulations. Working knowledge of CFR 820.30 Design Controls and ISO 14971. PHYSICAL/MENTAL REQUIREMENTSPhysical requirements include walking, standing, and performing analysis including written protocols and reports.

*EEO & Employment Eligibility*

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

*Principal Human Factors Engineer, Medical Device*
*Lake Forest, Illinois*

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