Sr MDR Biocompatability Specialist

Company: Aerotek
Location: Minneapolis
Posted on: April 10, 2021

Job Description:

Description:The individual in this role would be assigned to a business unit (certain types of products- Cardiac Rhythm Management CRM, ep, structural heart) and it will be digging up old data, seeing what we have, doing gap assessments to the new standards and potential changes since the initial profile. Deep diving into the biocompatability of a product family. This role will work closely with internal biocompatibility SME's and directly with program/project cross-functional teams to provide biocompatibility risk assessments, test strategy and deliverables in compliance with global regulatory requirements such as ISO 10993. The role requires knowledge of the medical device biocompatibility discipline throughout the product lifecycle and knowledge of biocompatibility regulations and guidance that affect assigned devices (Class I to Class III). Candidate must have strong ability to interpret biocompatibility standards/guidance and apply regulatory requirements as appropriate to product development and change activities for assigned devices. Candidate must have strong ability to identify required inputs, critically review and evaluate scientific information, and assess the significance of any gaps identifiedThe ideal candidate in this role would have previous experience writing toxicology risk assessments within the medical device space. Essential Responsibilities: 2+ years of recent biocompatibility experienceDevelop biocompatibility risk assessments in consideration of prior and available company materials, design and process information. Evaluate biological risk assessment in order to identify information gaps and discern which warrant additional testing and which do not.Propose potential testing strategies that satisfy timeline, cost, technical, and biological safety requirements. Critically review protocols, reports, toxicological risk assessments, and regulatory summaries in collaboration with cross-functional program teams, test laboratories, and suppliersAnalyze, interpret, and draw conclusions from biocompatibility testing, including, but not limited to, extractable and leachable chemical characterization and biological evaluations Interface with key business partners as directed and represent biocompatibility team on project/program teamsProvide leadership and technical guidance to Scientist/Specialist I and II of the Biocompatibility teamSkills:medical device, toxicology, gap analysis, Risk assessment, BiocompatibilityTop Skills Details:Biocompatibilitymedical devicetoxicologyAdditional Skills & Qualifications:2+ years of recent biocompatibility experience Need someone that is self motivated- a lot of the training is self-led/taught Direct job experience doing primarily 10993-1 biocompatibility evaluations for product development in a medical device company as this would be a large portion of their role BS in one or more of the following disciplines: Biomedical Engineering, Bioengineering, Biology (Biological Sciences), Molecular Cell Biology, Biochemistry, Materials Science, or Toxicology; advanced degree (MS or PhD) beneficial although comparable areas of study and industry experience is considered for the position4-6 years' industrial experience in the field of Medical Device, Pharmaceutical, or Biotechnology with expertise in biocompatibility, toxicology, and/or special process validationFundamental understanding or direct experience of the ISO 10993 standards, ISO 10993 biocompatibility materials and process risk assessment, biomaterials, toxicological assessment, extractable and leachable analysis, and medical device manufacturing processesDemonstrated ability to draw risked based conclusions, present and make recommendations based on technical inputs from multiple and varied functionsMust be team oriented, with the ability to work well on common deliverables with diverse cross-functional teams and to interact at the highest professional manner with all organizational levelsExcellent communication skills, both verbal and written, and interpersonal skills to successfully partner on varying levels ranging from cross functional to global multi-site and multi-business unitCapable of developing and driving to a detailed project plan with scheduled and defined dependencies between tasks and deliverablesThe ideal candidate in this role would have previous experience writing toxicology risk assessments within the medical device space. About Aerotek: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.

Keywords: Aerotek, Minneapolis , Sr MDR Biocompatability Specialist, Other , Minneapolis, Minnesota