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Takeda Pharmaceutical Newton, Massachusetts
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as a Use-safety Engineering Lead, Human Factors and User Research where you will manage Human Centered Design of Medical Devices and Combination Products. You will also manage usability technology landscaping , usability safety requirements, task analysis and use risk analysis, contributing to the design and development of the product user interface to support safe and effective use of the product for the intended use by the intended users in the anticipated use environment. As part of the Human Factors and User Research, you will report to Lead, Human Factors and User Research and work with mechanical, software, clinical, regulatory, packaging, labeling, and quality engineering disciplines. How you will contribute: Apply human performance and behavior principles, methodologies, and technologies to design user-centered Medical Devices and Combination Products Provide use-safety engineering and usability risk management expertise and leadership throughout product development in accordance with internal processes and external standards Conduct the known use problems analysis and use related risk analysis for products, updating analyses throughout the design and development of the product user interface. Work with HF leads on establishing the use safety product and system-level requirements and specifications, and support in designing Human Factors studies to iteratively evaluate product user interface - including hardware, software, packaging, instructional material, and training. Apply knowledge of applicable guidance, regulations, standards, and industry best practices to medical device and combination product design and development process. Prepare documentation to support medical device and combination product development activities including design controls. Work with regional regulatory bodies in product approval discussions, providing expertise on the use-related risk analysis. Draft responses to regulatory Human Factors Information Requests. Participate in internal and external quality audits. Mentor Human Factors and User Research Leads. Contribute to Human Factors standard operating procedures and templates development. Collaborate with cross functional team members from mechanical, software, clinical, regulatory, packaging, labeling, and quality engineering disciplines. Communicate with internal and external stakeholders. Minimum Requirements/Qualifications: Doctorate degree and 6 years / Master's degree and 8 years / Bachelor's degree and 10 years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, other relevant degrees in device design or biotech industry. A understanding of medical device and combination product usability risk management. Understanding and background in implementing Human Factors Engineering and Risk Management regulations and standards, including IEC 62366, HE75, ISO 14971, ISO 13485, 21CFR, and EU MDR. Be collaborative and flexible in approach to solving human factors challenges. We may ask you for up to 5-10% yearly travel, including domestic and international. What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan 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 and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More 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. Base Salary Range: $130,200 to $186,000, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. EEO Statement 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. Locations Lexington, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
Stanford University San Mateo, California
Full time
The Department of Pediatrics, Division of Neonatal and Developmental Medicine aims to provide optimum state-of-the-art care for critically ill and recovering neonates and infants. We are dedicated to the School of Medicine's mission of advancing and exploring innovative and novel biomedical, translational, and clinical research and education through the nurturing stimulation of interactions among basic and clinical scientists, clinicians, and educators throughout the School of Medicine and University, as well as with the private and public sectors. Through our integrated research, education, patient, and community outreach programs, we are committed to maintaining the highest standards of academic medicine and patient care. We are seeking a full-time, 100% FTE Clinical Operations Administrator (Administrative Assistant III) to provide clinical operations support as well as administrative support including travel and purchase reimbursements, travel arrangements, payment processing, event coordination, grant and contract submissions, and publications, for our LPCH NICU Medical Director and Director of Quality and Safety We believe Stanford's future success will be shaped by the diverse perspectives, unique experiences, and inclusive culture of its community. Duties include: Act on behalf of the supervisor, department manager, or chair in regards to establishing priorities and identifying and resolving problems that are administrative in nature. Oversee and/or perform duties associated with scheduling, organizing, and operating complex conferences, seminars, and events, including arranging with vendors for services, overseeing the production and distribution of materials, administering logistics, and managing event within budget. Compose and draft documents and correspondence for presentations, course handouts, grants, conferences, seminars, and reports; perform substantial editing and fact checking. Create, maintain, modify, and/or ensure accuracy of content in various unit documents, displays, reports, brochures, social media, and/or websites. Plan and schedule calendar(s) with limited consultation, resolve calendaring conflicts, and arrange travel in compliance with unit, university, and sponsor policies. Create complex reports and spreadsheets which may utilize specialized software and systems. Oversee and/or process a variety of complex financial transactions; produce, monitor, and reconcile budget statements; research, identify, and resolve discrepancies. May assist with capital or special equipment requests and/or vendor selection. Coordinate and monitor routine maintenance services completion. Plan and coordinate office moves and/or minor renovation projects. May lead staff or supervise day-to-day work of student and/or temporary workers, including scheduling, assigning, and prioritizing workloads, setting appropriate deadlines, reviewing work for quality and timeliness, and providing performance review input. - Other duties may also be assigned As an organization that receives federal funding, Stanford University has a COVID-19 vaccination requirement that will apply to all university employees, including those working remotely in the United States and applicable subcontractors. To learn more about COVID policies and guidelines for Stanford University Staff, please visit DESIRED QUALIFICATIONS: EDUCATION & EXPERIENCE (REQUIRED): High school diploma and four years of administrative experience, or combination of education and relevant experience. KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED): Advanced computer skills and demonstrated experience with office software and email applications. Demonstrated success in following through and completing projects. Excellent organizational skills and attention to detail. Strong verbal and written communication skills. Excellent customer service and interpersonal skills. Ability to prioritize, multi-task, and assign work to others. Ability to take initiative and ownership of projects. Ability to routinely and independently exercise sound judgment in making decisions CERTIFICATIONS & LICENSES: None PHYSICAL REQUIREMENTS : Constantly perform desk-based computer tasks. Frequently sitting. Occasionally stand/walk, reach/work above shoulders, grasp lightly/fine manipulation, grasp forcefully, use a telephone, sort/file paperwork or parts, lift/carry/push/pull objects that weigh up to 10 pounds. Rarely twist/bend/stoop/squat, kneel/crawl. - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job. Additional PHYSICAL REQUIREMENTS: WORKING CONDITIONS: Additional WORKING CONDITIONS:
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