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Pay Range: $43.33hr - $48.33hr Requirement/Must Have: Bachelor’s Degree in Engineering or related technical discipline. Proven experience working in a regulated industry (ISO 9001 or similar). Strong proficiency in Microsoft Excel, Word, and Adobe Acrobat. Excellent writing, documentation, and communication skills. Ability to manage multiple projects simultaneously. Ability to work independently and within cross-functional teams. Experience: Minimum 8 years in a medical device product development or regulated environment. Experience writing, reviewing, and managing engineering documentation including requirements, specifications, test protocols, and reports. Experience with Design History Files (DHF), Engineering Change Orders (ECOs), and documentation traceability. Experience with Siemens Polarion, Agile PLM, or similar lifecycle management and requirements tools. Experience supporting cross-functional teams through product development lifecycle stages. Responsibilities and Duties: Compile and update engineering design control documents (e.g., requirements, risk analyses, verification/validation documents). Create and manage Design History Files (DHF) and associated documentation using Agile. Maintain traceability using Siemens Polarion and generate trace and verification reports. Coordinate documentation and ECOs for design reviews and product changes. Collaborate with Technical Publications to ensure alignment of user manuals, labels, and training materials with design documentation. Assist subject matter experts in authoring and editing design control documentation. Support cross-functional teams in structuring and maintaining document architecture. Should Have: Strong understanding of design control requirements in medical devices. Working knowledge of risk analysis, FMEAs, and compliance practices. Ability to coordinate multiple assignments and drive issues to resolution. Attention to detail and commitment to producing accurate documentation. Strong interpersonal and collaboration skills. Skills: Siemens Polarion. Agile PLM or similar system. Risk Analysis & FMEAs. Microsoft Office Suite. Documentation Traceability. Engineering Change Control. Hardware/software systems development (preferred).