Product Development Engineer

Requirements Bachelor’s degree in Mechanical Engineering or Biomedical Engineering Minimum 2 years’ experience in product development; medical device or another highly regulated industry is highly preferred Proficient in 3D CAD modeling and Engineering Drawings (SolidWorks or similar). Strong technical writing skills and experience writing product requirements, specifications, test protocols and test reports, and engineering rationales. Core Competencies Demonstrates expertise in New Product Development for surgical implants and medical devices, ensuring compliance with ISO standards and FDA regulations. Proficient in technical documentation, risk management, and 3D CAD modeling. Highest-signal resume keywords New Product Development ISO 13485 Compliance 3D CAD Modeling Technical Writing Risk Management (FMEA) Hard Skills Finite Element Analysis Geometric Dimensioning & Tolerancing (GD&T) Design Verification & Validation Biocompatibility Evaluation Sterilization Evaluation Soft Skills Attention to Detail Analytical Thinking Industry Keywords Medical Device Regulated Industry

ISO 14971

ISO 10993-1

FDA 21CFR Part 820.30 Tools & Technologies SolidWorks Engineering Drawings Engage in executing the main elements of New Product Development to introduce surgical implants, prosthetics, and instruments to market. Participate in planning and execution of Design Verification & Validation activities. Generate product development documentation ensuring compliance with internal operating procedures, ISO 13485 and FDA 21CFR Part 820.30. Conduct risk management activities (FMEA) and document results ensuring compliance with internal procedures and ISO-14971. Conduct biocompatibility and sterilization evaluations and generate documentation ensuring compliance with internal procedures, ISO 10993-1 and ISO 11737. Perform Finite Element Analysis if needed. Review dimensions of parts, materials to be used, relations of one part to another, and relation of various parts to whole structure of product lines. Review and approve drawings, applying knowledge and experience utilizing Geometric Dimensioning & Tolerancing (GD&T) per ASME Y14.5. #J-18808-Ljbffr Jobtailor