Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Staff Engineer, Human Factors and User Experience based in our Lexington, MA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission.
Lead Human Factors programs in order to provide best in class usability and enhanced user experience for Takeda device users
Ensure regulatory success by making sure that the HFE work is done in compliance with IEC 62366 & regulatory body (example, FDA) expectations.
Partner and influence peers within device, clinical, commercial, regulatory and quality organizations to drive improvement of device development processes
Lead HFE & User Experience strategy for the assigned medical devices and combination products.
Produce all the HFE deliverables throughout medical device development (Examples, HFE Plan ,Task Analysis, Use Specification, User-interface requirements, HFE/UE Summary report etc.) in compliance with IEC 62366 & regulatory agency expectations
Provide HFE & UX input for user interface design and development (hardware, GUI, labeling etc.)
Provide input to Use-Related Risk Analysis
Identify & execute on opportunities for enhancing and harmonizing user experience.
Work with external partners to conduct formative and summative studies.
Author HFE sections of the regulatory submissions (example, 510K)
Lead the design and development of Instructions for Use (IFU).
Plan & execute on post launch Human Factors activities
Support other HFE/UX team members on any of the above tasks as needed.
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise(Breadth and depth of knowledge, application, and complexity of technical knowledge)
In-depth understanding of Human Factors research methods
Experience with medical device and/or combination product
Experience conducting Human Factors formative and summative studies.
Familiarity with IEC 62366-1/2, FDA HF Guidance, EU MDR usability expectations
Working knowledge of relevant medical device standards ISO 14971, IEC 60601-1-8, HE75
Leadership(Vision, strategy and business alignment, people management, communication, influencing others, managing change)
Effective oral and written communication skills
Decision-making and Autonomy(The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)
Ability to make decisions on HF strategy, testing execution, and documentation best practices
Interaction(The span and nature of one’s engagement with others when performing one’s job, internal and external relationships)
Active collaboration with internal cross-functional teams and external stakeholders
Innovation(The required level of scientific knowledge, knowledge sharing, innovation and risk taking)
Finding innovative solutions for enhancing usability and user experience
Complexity(Products managed, mix of businesses, internal and/or external business environment, cultural considerations)
Ability to work on multiple products with varying degrees of complexity.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
Doctorate degree and 2 years of Human Factors Engineering, Usability Engineering, User Experience and other relevant degrees in medical device or biotech industry or consumer technology. OR
Master's degree and 5 years of Human Factors Engineering, Usability Engineering, User Experience and other relevant degrees in medical device or biotech industry or consumer technology OR
Bachelor's degree and 8 years of Human Factors Engineering, Usability Engineering, User Experience and other relevant degrees in medical device or biotech industry or consumer technology
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
Tuition reimbursement and Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
Community Outreach Programs
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
Internal Number: R0031452
Takeda is a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide. Our passion and pursuit of potentially life-changing treatments for patients are deeply rooted in over 230 years of distinguished history in Japan. Today, we are the number one pharmaceutical company in Japan and a global industry leader. Our best-in-class products are marketed worldwide, positively impacting millions of lives.
Takeda strives to have a workforce as diverse as the patients we serve. We are committed to embracing differences, exploring possibilities and developing our employees. Our success depends on fostering an inclusive environment where all employees are welcomed, empowered and inspired to use their unique voices and talents. This is how we will find innovative approaches to serve our patients, customers and communities. This is how we will reach our highest potential together.
Learn more at takedajobs.com