Mechanical Design Engineer

The Design Engineer II is a mid-level engineering role responsible for contributing to the design, development, and improvement of medical devices, specifically focusing on spinal implants and instruments. This role involves working closely with senior engineers and cross-functional teams to bring new products to market, support existing product lines, and ensure compliance with industry standards and regulations. The Design Engineer II will participate in all stages of the product development lifecycle, from concept to production, with increasing responsibility and independence compared to a junior design engineer. Responsibilities: Execute activities associated with the design and development of new products, and custom products. Create detailed engineering drawings, 3D models, and specifications using CAD software, applying GD&T (Geometrical Dimensioning and Tolerancing). Support the conceptualization and design of spinal implants and instruments, incorporating human factors/usability engineering principles. Assist in the generation of rapid prototypes (e.g., SLA, FDM) and proof of concepts for evaluation and testing. Lead minor new product development projects or line extension projects, working under the guidance of senior engineers or project managers. Manage project timelines, coordinate cross-functional team activities, and ensure key deliverables are met. Contribute to the creation and maintenance of project documentation, including project plans and design history files. Collaborate with manufacturing, quality, regulatory, and other departments to ensure designs are manufacturable and compliant with relevant standards. Participate in design reviews, providing technical input and feedback to improve product functionality and manufacturability. Engage with Marketing and Sales teams to understand customer needs and translate them into product design requirements. Participate in risk management activities such as dFMEA and pFMEA. Support design verification and validation activities, including mechanical testing, design of experiments, and cadaveric lab evaluations. Assist in the development and execution of cleaning, packaging, and sterilization validation activities. Assist in preparing technical documentation to support regulatory submissions (e.g., 510(k) filings). Ensure all design activities comply with GMP, the company's design control procedures, and the quality management system. Identify opportunities for design improvements and cost reductions through the application of DFM (Design for Manufacturability) principles. Stay updated on industry trends, materials, and technologies to incorporate the latest advancements into product designs. Contribute to intellectual property (IP) development by generating novel ideas for inclusion in the company's IP portfolio.         Qualifications:   Bachelor's Degree in Mechanical Engineering, Biomedical Engineering, or a related field. Master's degree is a plus but not required. 2-5 years of experience in product design and development, preferably in the medical device industry. Hands-on experience with design control processes and regulation compliance (ISO 13485, 21 CFR Part 820). Experience with CAD software (e.g., SolidWorks) and proficiency in GD&T. Strong mechanical design aptitude and problem-solving skills. Experience with DFM and familiarity with manufacturing processes such as milling, turning, and additive manufacturing. Ability to work independently and as part of a cross-functional team. Excellent communication skills, both written and verbal. Proficiency in FEA (Finite Element Analysis) and experience with rapid prototyping techniques. Ability to manage multiple tasks and projects simultaneously, with a focus on meeting deadlines.

Created: 2024-10-19