Sr Bio/ Toxicologist

• 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 internal and external laboratories as appropriate.
• 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%

Must Have: Minimum Requirements

• Bachelors degree required

• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

Nice to Have

• 5 years of experience in the medical device or pharmaceutical industry performing or overseeing biological safety assessments, related risk assessments, and or equivalent experience.

• 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.

• 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.

About Medtronic

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.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)