Shanghai, CHN
36 days ago
MTC-Senior Scientist-Shanghai
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. **A Day in the Life** The Scientist/Senior Scientist will provide an advanced technical expertise in biocompatibility assessment for Greater China R&D organization. He /she will manage the biological safety compliance process according to ISO, AAMI, GB, YY, and other country specific regulatory policies, guidelines, and procedures. He/she will assess material safety, conduct biocompatibility assessments, develop biocompatibility test strategy, select test methods, interpret results, solve technical issues, and address questions from regulatory agencies. He/she will conduct biocompatibility evaluation to support product development programs, regulatory submissions, process changes, and quality control procedures. He/she will serve as a liaison with Medtronic’s biocompatibility/toxicology experts internally, and between standard organizations, industry peers, government laboratories, and research institutions to contribute on biological safety standard development externally. + Be responsible for planning, initiating, and executing device biological safety evaluation through medical device during material scouting, product development, and regulatory submission process. + Serve as a biological safety liaison between global product development teams. Provide guidance for testing related to new investigational and strategic device development programs during PDP. Provide professional advices and interpretations on regulatory requirements related to medical device submissions for all divisions. + Develop plans, reports, conduct trouble shooting, and interpret test outcome of biological safety testing, bioanalytical and chemical characterization data to determine if device safety is sufficiently addressed. + Ensure biological safety compliance of products developed at China R&D according to ISO 10993, GB/T 16886 standards, country specific policies, regulations, and guidelines (US FDA, EU, Japan, and China). + Evaluate biocompatibility and toxicological contract research organizations globally, screen vendors to meet different business purposes. Conduct technical audits at CROs. + Draft SOPs and other supportive documents as needed to provide directory and guidance on device safety assessment. + Complete other assigned research tasks assigned by management. **Physical Job Requirements** The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.  **Benefits & Compensation** **Medtronic offers a competitive Salary and flexible Benefits Package** A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). **About Medtronic** We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here (http://www.medtronic.com) We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. **We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. **We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. **This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will… + **Build** a better future, amplifying your impact on the causes that matter to you and the world + **Grow** a career reflective of your passion and abilities + **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: **Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. **Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. **Better outcomes for our world** . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. **Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) . For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email AskHR@medtronic.com To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com
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