Senior Manager, Human Factors and User Experience

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Senior Manager, Human Factors and User ExperienceLexington, MAHybridOBJECTIVES/PURPOSEProvide leadership and consultative expertise for all human factors and user centered design related aspects on development projects.Strive for regulatory success of projects by making sure that the HFE work is done in compliance with IEC 62366 & regulatory body (example, FDA) expectations.Collaborate with cross-functional teams to integrate human factors considerations into product development processes.ACCOUNTABILITIESDevelop and implement human factors strategies aligned with product development goals. Ensure compliance with relevant regulatory requirements and industry standards.Drive continuous improvement in human factors processes and methodologies.Support and prepare justifications for Human Factors strategies.Lead/coordinate HFE & User Experience strategy for the assigned medical devices, combination products and digital solutions forming the part of Takeda therapy ecosystem.Design and oversee usability studies, including participant recruitment, protocol development, and data analysis.Interpret usability test results and provide actionable recommendations for product improvement.Collaborate with cross-functional teams to incorporate usability findings into design iterations.Oversee and/or generate the HFE deliverables throughout medical device development (Examples, HFE Plan, Task Analysis, Use Specification, use related risk analysis, User-interface requirements, HFE/UE Summary report etc.) in compliance with IEC 62366 & regulatory agency expectations.Support inquiries, audits, and discussions with regulatory agencies, test labs, and notified bodies.Manage HF, UI/UX vendors on the assigned projects.DIMENSIONS AND ASPECTSTechnical/Functional (Line) ExpertiseIn-depth understanding of Human Factors research methodsExperience with medical device and/or combination product and digital health solutions.Experience conducting Human Factors formative and summative studies.Familiarity with IEC 62366-1/2, FDA HF Guidance, EU MDR usability expectationsWorking knowledge of relevant medical device standards ISO 14971, IEC 60601-1-8, HE75LeadershipEffective oral and written communication skillsMentor and develop team members to enhance their skills and capabilities.Collaborate with cross-functional teams to integrate human factors considerations into product development processes.Decision-making and AutonomyAbility to make decisions on HF strategy, testing execution, and documentation best practices.InteractionWork closely with product design, engineering, and quality teams to integrate human factors considerations throughout the product development lifecycle.Collaborate with external partners, vendors, and consultants to augment human factors expertise.InnovationFinding innovative solutions for enhancing usability and user experienceComplexityAbility to work on multiple products with varying degrees of complexity.EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:Master'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

Considering applying for this job Do not delay, scroll down and make your application as soon as possible to avoid missing out.ORBachelor's degree and 10 years of Human Factors Engineering, Usability Engineering, User Experience and other relevant degrees in medical device or biotech industry or consumer technologyWhat Takeda can offer you:Comprehensive Healthcare: Medical, Dental, and VisionFinancial Planning & Stability: 401(k) with company match and Annual Retirement Contribution PlanHealth & Wellness programs including onsite flu shots and health screeningsGenerous time off for vacation and the option to purchase additional vacation daysCommunity Outreach Programs and company match of charitable contributionsFamily Planning SupportFlexible Ways of WorkingTuition reimbursementMore about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.#LI-hybridTakeda Compensation and Benefits SummaryWe understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.For Location:Lexington, MA

U.S. Base Salary Range:$133,000.00 - $209,000.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.Locations Lexington, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time#J-18808-Ljbffr