Senior Human Factors and Design Validation Engineer, Device and Combination Products

Why Patients Need You

Technology impacts everything we do. Pfizer's digital and 'data first' strategy focuses on implementing impactful and innovative technology solutions across all functions from research to manufacturing. Whether you are digitizing drug discovery and development, identifying solutions, or making our work easier and faster, you will be making a difference to countless lives.

What You Will Achieve

Your technical and interpersonal skills will help us develop robust combination products and delivery devices for our business. You will support a range of activities, such as executing human factors studies, influencing implementation of design features to mitigate use risks, and performing research to understand the intended users of our products.

The primary responsibility for Senior Human Factors & Design Validation Engineer is to ensure that assigned devices/combination products, 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.

How You Will Achieve It

• 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 with Systems function. Provide input into risk management activities for assigned projects ensuring risk files are aligned with human factors activity and feedback
  
• Conduct research to understand the intended user. Provide device ergonomics and usability input to device design inputs and device design specifications
  
• Generate Human Factors and Design Validation objectives and deliverables plan, and document goals and strategies within a Design Validation and HF plan and Human Factors Engineering Report
  
• Manage all human factors (HF) and design validation 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 protocols and reports
  
• Project manage the supply, assembly and testing of materials for use in HF studies and associated documentation
  
• Ensure timely execution of HF studies or comparison analysis (Threshold Analysis) for assigned projects
  
• Provide HF study feedback and/or recommended mitigation actions into the project Core Team
  
• Provide usability input and support for generation of assigned Pfizer device Instructions for Use (IFU), device labelling and packaging
  
• Support the generation of device regulatory submission data and responses to regulatory body inquiries related to human factors. Ensure high quality deliverables in compliance with Regulation and local procedures.
  
• 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
  

Qualifications

Must-Have

• Bachelor's Degree in biomedical, human factors engineering, experimental psychology, cognitive psychology, industrial design or a related field with 4-5 years of relevant medical device, combination product usability or human factors experience; OR Master's degree in one of the above fields from an accredited university and a 1-3 years of relevant industry experience.
  
• Understanding of FDA regulations and usability standards, including 21 CFR 820.30 Medical Device Design Controls, ISO 13485, ISO 14971, AAMI HE75, BS EN 62366.
  
• Experience working with third party Human Factors vendors.
  
• FDA Guidance including Applying Human Factors and Suability Engineering to Medical Devices, Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA, Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development, and working knowledge of Current Good Manufacturing Practice Requirements for Combination Products.
  

Nice-to-Have

• Previous experience in combination products risk management.
  

PHYSICAL/MENTAL REQUIREMENTS

• Physical requirements include sitting, walking, standing, and performing analysis including written protocols and reports.
• Relocation support available

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Travel to human factors studies as needed
Relocation support available

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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.

Research and Development