Together, They can change healthcare worldwide. At Medtronic, They push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
Post : Sr Scientist
Job Description:
• Provides biological safety assessment to achieve ISO 10993 compliance and to support product development activities.
• Provides guidance in the development of product and selection of materials to ensure that released designs meet biological safety requirements. The Senior Toxicologist is responsible for the timely completion of technical deliverables.
• Prepares documentation of biological assessment efforts using sound scientific principles. Coordinates biological testing activities by partnering with MDT Physiological Research Laboratories, NAmSA, WuXi AppTec, Toxicon, or other approved laboratory as appropriate. Provides primary interface with MDT Physiological Research Laboratories for MDT XMD.
• Establishes and integrates risk management process as part of the biological evaluation program in a manner that complies with ISO 10993.
• Assesses the biological safety impact from manufacturing and supplier changes on patient-contacting devices.
• Consults on the biological safety impact from device field issues.
• Develops or identifies resources and provides training to aid product development activities with biological evaluation process. (Web-based biomaterials support, biomaterials testing databases).
• Mentors engineers.
• All activities must be performed in compliance with the Quality System.
• Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
• All other duties as assigned.
Candidate Profile
• Bachelor of Science degree required.
• 5+ years of experience in the medical device or pharmaceutical industry performing or overseeing biological safety assessments, related risk assessments, and or equivalent experience.
• In-depth knowledge of biological impact of foreign materials in the human body.
• Knowledge of applicable ASTM, ISO, FDA and EN standards. An in-depth understanding of ISO 10993 – Biocompatibility standard.
• Computer proficiency using word processors, spreadsheet, project management, and statistical software programs is required.
• Master of Science or PhD in toxicology, physiology, or related discipline preferred.
• Strong problem solving and analytical skills.
• Able to apply advanced scientific principles.
• Good oral and written communication skills.
• Excellent presentation skills
• Able to handle multiple tasks/projects and manage priorities accordingly.
• Able to work in a team environment, including cross-functional teams, and exert influence without alienating others.
Additional Information
Experience : 5+ year
Qualification : B.Ss, M.Sc, Ph.D
Location : Hyderabad, Andhra Pradesh
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 30th November, 2019
See All M.Pharm Alerts Ph.D Alerts Hyderabad Alerts
See All Other Jobs in our Database