Posted in Admin - Clerical 13 days ago.
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Human Factors and User Research - Senior Manager for our Medical Device Center of Excellence group 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.
As a Human Factors and User Research Senior Manager, you oversee Human Centered Design of Medical Devices and Combination Products. You will be integral to design and development of product user interface including hardware, software, packaging, labeling, and instruction material to support safe and effective use of the product for the intended use by the intended users in the anticipated use environment. You will report into the Human Factors and User Research department.
You will implement Human Factors strategy in compliance with regional regulatory guidance and User Research strategy in compliance with Quality Management System.
You will develop Human Factors Product and System level requirements in alignment with Target Product Profile.
You will conduct exploratory research to gather user insights and design trends and evaluate user interface concepts.
You will translate user needs into user experience and interface requirements and specifications.
You will design and execute Human Factors studies to iteratively evaluating product user interface – including hardware, software, packaging, instructional material, and training.
You will conduct Task and Known Use Problem Analyses.
You will perform use-safety engineering through Use-related Risk Analysis.
You will develop Human Factors Validation Protocols and Reports.
You will manager Human Factors, Industrial Design, and User Research vendors.
You will support regulatory Human Factors Information Requests.
You will develop Human Factors Summary Reports in compliance with FDA guidance and Usability Engineering Files in compliance with IEC and ISO standards.
You will contribute to Human Factors standard operating procedures and templates development.
You will apply functional knowledge of applicable guidance, regulations, standards, and industry best practices to medical device and combination product design and development process.
You will prepare documentation to support medical device and combination product development activities including design controls.
You will collaborate with cross functional team members from mechanical, software, clinical, regulatory, and quality engineering disciplines.
You will support internal and external quality audits.
You will communicate with internal and external key stakeholders.
You will mentor Human Factors Engineering Leads.
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
Education and Experience:
Doctorate degree and 6 years of experience in Human Factors Engineering, Biomedical Engineering, Industrial Engineering, other relevant degrees in device design or biotech industry.
Master's degree and 8 years of experience in Human Factors Engineering, Biomedical Engineering, Industrial Engineering, other relevant degrees in device design or biotech industry.
Bachelor's degree and 10 years of experience in Human Factors Engineering, Biomedical Engineering, Industrial Engineering, other relevant degrees in device design or biotech industry.
May require approximately up to 20% travel
WHAT TAKEDA CAN OFFER YOU
401(k) with company match and Annual Retirement Contribution Plan
Tuition reimbursement 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
Effective November 1, 2021, absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. As of the same date, absent an approved religious or medical reason, US field-based employees, employees must be fully vaccinated in order to continue in their current roles. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. Candidates are encouraged to speak with their recruiter to seek further information on the applicable guidelines for the Business Unit/Function for which they have applied.
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
*This job posting excludes CO applicants*
Takeda 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.
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