Human Factors Engineer
PharmaBiotechMedTechRegulatory AffairsQuality Assuranceregulatory submissionfdacroraveinformaws
Job description
Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D Position Summary Join us as a Human Factors Engineer where you will help design easy-to-use and safe healthcare solutions. You will work closely with cross-functional teams to understand user needs and bring these insights into the design process. Our team values curiosity, empathy, and collaboration. At GSK, you will grow your skills, make a real difference in patients’ lives, and be part of a mission to unite science, technology, and talent to get ahead of disease together. Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: - Lead human-centred design activities throughout all stages of device development to ensure products meet user needs. - Plan and execute user studies, including early handling tests and design validation, to gather meaningful feedback. - Conduct user-related risk assessments and integrate findings into design decisions to improve safety and usability. - Work closely with engineers, regulatory, clinical, and quality teams to solve design and regulatory challenges. - Manage relationships and communications with external vendors and internal stakeholders to support project goals. - Contribute to regulatory documentation by preparing clear, accurate sections related to human factors and usability. Why You? Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals: - Degree in Mechanical Engineering, Biomedical Engineering, Human Factors, or a related field. - Proven experience applying human factors engineering principles in medical device or combination product development. - Understanding of human factors regulatory guidelines such as IEC 62366 and FDA usability requirements. - Experience planning and conducting human factors studies, including usability testing and risk assessments. - Knowledge of integrating user needs and risk information into design and validation activities. - Strong communication skills to work effectively within cross-functional teams and with external partners. Preferred Qualification If you have the following characteristics, it would be a plus: - Experience with global regulatory submissions and authoring sections of human factors files. - Ability to analyse user data and translate insights into clear design improvements. - Familiarity with design for manufacture principles. - Strong organisational skills with the ability to manage multiple projects and deadlines. - Evidence of being a proactive team player who adapts well to changing priorities. - High attention to detail and commitment to quality. Working Arrangement This role is based at GSK’s Research & Development site in Ware, Hertfordshire, United Kingdom. We offer a flexible hybrid working arrangement with an expectation for regular on-site presence. Occasional travel may be required. Are you ready to contribute your talent and make a meaningful impact on healthcare? Apply now to join GSK and help create solutions that improve lives around the world. We welcome your application and look forward to learning about how you can help us get ahead of disease together. Skills CMC Strategy, Data-Driven Decision Making, Data Integrity, Debate Moderation, Digital Fluency, GxP Regulations, Lean Management, Problem Solving, Process Optimization, Project Leadership, Risk Awareness, Scientific Writing, Technology Transfer Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at UKRecruitment.Adjustments@gsk.com where you can also request a call. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/
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