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Sr. Human Factors, Design Validation Engineer, Device and Combination Products

Company: Pfizer
Location: Lake Forest
Posted on: September 13, 2020

Job Description:

Sr. Human Factors, Design Validation Engineer, Device and Combination Products United States - Illinois - Lake Forest

Why Patients Need You Why Patients Need You

Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling Pfizer’s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.

What You Will Achieve Device and Combination Product (DCP), based in Lake Forest IL, is a drug device combination design and development organization focused on improving patients’ lives through customer-focused innovation and broad-based access to quality medicines and products. Supporting the Pfizer Hospital business unit, the Senior Human Factors & Design Validation Engineer will have the opportunity to bring your expertise to enhance the usability and ensure the safe use of medical devices/combination products by the many patients, families and healthcare providers we serve across the globe.

As part of the Pfizer product development teams, the Senior Human Factors Engineer will collaborate with internal functions and external human factors partners in developing the planning and execution of human factors engineering formative and summative studies; researching unmet needs, user anthropometry and ergonomics; performing heuristics with the goal of bringing customer-centric design and value to improve the quality of life of our patients.

How You Will Achieve It Lead the activities for Pfizer device human factors engineering for assigned product development projects

Provide input into risk management activities for assigned projects ensuring product design and risk files are aligned with human factors activity and feedback

Act as internal Subject Matter Expert for assigned human factors (HF) and design validation activities with HF vendors, including overall project HF plan, generation of study brief, collaboration with HF vendor, providing relevant study materials and documentation, generation and approval of associated protocols and reports

Collaborate with internal stakeholders including Systems & Risks Engineering, Regulatory, Labelling, Packaging to develop strategies for product submission, meeting packages, and responses to questions from health agencies.

Provide device ergonomics and usability input to device design inputs and device design specifications

Owner of the Human Factors and Design Validation strategies and plan, including user research in early stage discovery of unmet needs, clinical requirements, standard of care and product concept evaluation

Project manage the supply, assembly and testing of materials for use in HF studies and associated documentation

Provide usability input, guidance and best practices for medical device usability engineering based on ISO 14971, IEC 62366, AAMI HE75 to support product design, device Instructions for Use (IFU), labelling and packaging

Qualifications Must-Have Bachelor’s Degree in biomedical, human factors engineering, experimental psychology, cognitive psychology, industrial design or a related field with minimum of 4-5 years of relevant medical device, combination product usability or human factors experience; Master's or PhD in one of the above disciplines from an accredited university and a 1-3 years of relevant industry experience.

Understanding of FDA regulations and usability standards, including ISO 14971, AAMI HE75, IEC 62366.

Experience working with third party Human Factors vendors

Ability to influence and collaborate with peers to achieve meaningful outcomes and create business impact

Agile with ability to work collaboratively with various functions

Excellent verbal and written communication skills

Attention to details

Nice-to-Have FDA Medical Device Design Control 21CFR820.30

Experience with Adobe Creative Suite

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.

Information & Business Tech

Posted 2 Days Ago

About Us Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.

Keywords: Pfizer, Lake Forest , Sr. Human Factors, Design Validation Engineer, Device and Combination Products, Other , Lake Forest, California

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