Senior researcher / group leader
Careers that Change Lives
This position has the responsibility and authority to coordinate studies providing documented scientific support, and direction for biological evaluation of medical devices and materials. This position will establish and maintain a biological evaluation program that integrates risk management. This position provides technical guidance to engineers and/or project management during the design process to ensure material selection and device configurations that are biologically safe for use. This position will improve the biological evaluation process using databases, information systems, and training programs.
A Day in the Life
• 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.
• Travel requirement: Less than 10%
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.
Nice to Haves:
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.
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services 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.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team.
Let’s work together to address universal healthcare needs and improve patients’ lives.Help us shape the future.
Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.
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.
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