Aerotek Microbiologist-Medtronic (Can Be Remote) in Brooklyn Park, Minnesota
Local candidates preferred but will consider remote candidates anywhere in the US also. Biocomp focused position.
In addition to being responsible for the design evaluation and testing of new and existing medical devices, other tasks may include but are not limited to: * Provides biological safety assessment to achieve ISO 10993 compliance and to support product development activities * Assesses the biological safety impact from manufacturing, design, and supplier changes on patient-contacting devices * Leverages material and chemical composition data to satisfy chemical characterization requirements * Establishes and integrates risk management process as part of the biological evaluation program in a manner that complies with ISO 10993 * Performs gap analysis of existing data to current ISO 10993 standards * Consults on the biological safety impact from device field issues * Independently creates protocols and reports to comply to applicable standards and FDA guidance documents * Follows applicable procedures and standard guidance * Coordinates and performs test activities necessary to execute protocols
Responsibilities may include the following and other duties may be assigned.
Analyzes chemical, biological or microbiological products, raw materials, inprocess materials, release test samples or stability samples in support of the company's quality program.
Interprets and evaluates the analyses in terms of accuracy and precision compared against established specifications (ISO 10993 and other regional guidance) and recommends test plan and implements corrective action where necessary.
May also be involved in establishing requirements for the transfer of methodology from R&D.
Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
microbiology, sterilization, ISO 10993
Top Skills Details:
ISO 10993 Sterilization Microbiology 2 years
Additional Skills & Qualifications:
2 years experience with ISO 10993
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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