Scientist

Medtronic is working with new partners, in new ways to improve global healthcare. With the integration of Covidien as our Minimally Invasive Therapies Group, we can address the healthcare needs of more people around the world than ever.

The Scientist has knowledge of biological safety evaluation, and assess health based risks of animal derived tissue products and device safety to meet global requirements for medical device use. The Scientist will have overall responsibility for the design and initiation of the health based risk assessments of material and device safety evaluations and subsequent safety studies, and oversees the technical completion of these studies as well as the interpretation, analysis, documentation and reporting of results with minimal directions from Manager.

* Addresses concernsrelated to device regulatory submission documentation, supplier, and device manufacturing process changes * Perform biological safety evaluation and risk assessment of animal origin material containing devices and their component materials, and process changes in accordance with ISO10993 and other national and international standards * Design and initiate health risk assessments of materials, device safety evaluation, and subsequent safety studies; oversee technical completion of the studies as well as interpretation, analysis, documentation, and reporting of the study results. * Literature review and toxicity assessment on chemical extractable and leachable from materials and/or devices in direct or indirect contact with human blood and tissues. * Provide guidance and technical expertise for chemical testing perform in house * Oversees and manages contractlabs performing studiesas well as analysis and interpretation of the results of the biological assays. * Critically review raw data to support laboratory testing, writes test protocols and reports. * Supports regulatory submissions * Interfaces with R&D, Quality, Regulatory and Manufacturing departments to work on assigned projects * Prepares plans, schedules and manages projects. * Performs other duties as assigned.

**Required Education:** B.S. degree in Biology Life science / technical discipline **Required Years Of Experience:** 2+ years experience in Biology or Chemistry **Desired/Preferred Qualifications:** * Good written and verbal communication skills, communicating clearly and concisely, both orally and in writing * Proficient in Math skills, especially in Microbiology/Sterilization Science math formulas and calculations * Computer literate with focus Excel, Word, PowerPoint, Visio, and Microsoft Project * Knowledge of good laboratory practices and safety * Demonstrate good documentation practices. * Good laboratory practices * Knowledgeable with ISO standards: ISO 22442 series, ISO 10993 series, ISO14160, and ISO 11135-1. * Strong technical skills in peer literature review, toxicity assessment / testing for medical device, and biocompatibility study. * Conduct without direct supervision and exercises considerable latitude in determining technical objectives of assignment. Completed work is reviewed from a relatively long-term perspective, for desired results. * Demonstrate understanding of cGMP requirements. * Strong technical leadership skills