Junior/Associate Biomedical EngineerDescription: Use historical documents in hard copy and electronic formats to retrospectively construct the design and development history of multiple drug/device combination products in accordance with company document control Standard Operating Procedures (SOPs) and Food and Drug Administration (FDA) regulations. Conduct gap analyses and support efforts to fill identified gaps. This position requires a sustained high level of attention to detail and the ability to review and read documents for the majority of the day. Responsibilities: Understand and apply design control SOPs and FDA Guidance. Understand and apply design control regulations FDA 21 CFR 820.30 & FDA 21 CFR Part 4. Understand, categorize, and summarize a variety of documents, such as engineering drawings, test reports, manufacturing reports, memos, correspondences, purchase orders, and meeting notes. Recognize when documents relate to each other and organize associated documents appropriately. Reconcile and harmonize work across the team. Navigate through multiple electronic storage systems to access files. Create flowcharts, explanatory documents, and project plans. Work with project teams, vendors and suppliers and perform risk management to facilitate gap analysis. Work with project teams, vendors and suppliers, and use primary historical documents to write combination product design control documentation. Identify gaps in design history files in accordance to company standards, as well as regulatory requirements including 21 CFR Part 4. Junior/Associate Biomedical EngineerJunior/Associate Biomedical Engineer W2 ONLY NO CORP TO CORP Qualifications: Bachelor of Science in Biomedical Engineering or Mechanical Engineering. Any experience or further Degrees are nice-to-haves, only. Some knowledge of drug/device combination products is desirable. Strong communications skills, ability to write concise technical documents. Strong reading comprehension skills. Proficient at deciphering handwritten text. Adept in Microsoft Office, especially Excel. Ability to maintain focus while doing repetitive tasks. Strong attention to detail and ability to think critically. Quickly adapt to multiple electronic file storage system software. Comfortable working under deadlines. Ability to work with colleagues from different disciplines and at all levels. Comfortable working as part of a team and independently. Junior/Associate Biomedical Engineer