Are you a technical expert and innovative leader looking to make a significant impact in product design and development? We are seeking a Principal R&D Engineer to manage and execute key design projects while mentoring other engineers. This role offers the opportunity to lead major product development initiatives from concept to production and contribute to the company's short-term and long-term goals. Primary Duties & Responsibilities As a Principal R&D Engineer, your responsibilities include: - Leading, participating in, and supporting activities throughout product development, including: - Concept generation - Project planning, design, and execution stages - Prototyping, design for manufacturability (DFM), design for inspection (DFI) - Risk assessments, pilot production, and design reviews - Verification, validation, and testing (protocol authorship, physical testing, reports) - Pre-production and full production launch - Demonstrating expertise in material selection, manufacturing methods, inspection techniques, and critical measurements. - Engaging directly with customers alongside sales and marketing to gather design ideas, document concepts, and transition them into high-quality production-ready products. - Ensuring compliance with the company's design quality system. We're looking for candidates with the following qualifications: Design Expertise - Expert CAD knowledge (preferably SolidWorks) for creating parametric models and ASME Y14.5-compliant prints. Manufacturing Feasibility - Proficient in interacting with design and manufacturing teams to balance manufacturability, reliability, and cost-effectiveness. Analytical and Technical Expertise - Advanced knowledge of CAD design, 3D print generation, FEA simulations, and ISO standards. Communication and Leadership - Strong ability to communicate schedules, budgets, designs, and testing results effectively to teams and stakeholders. Customer-Centric Approach - Ability to generate product designs based on customer input and surgeon feedback. Hands-On Approach - Comfort with cadaver work, surgical settings, and detailed research experiments to test feasibility. Collaborative Team Player - Proven ability to work on cross-functional teams and assist in creating design documentation for medical devices. To excel in this role, you should demonstrate: - Exceptional organizational and communication skills. - Strong attention to detail. - Expertise in product development, material selection, and industry best practices. - A desire to work on complex engineering problems and mentor your peers to grow the team's capabilities. Educational and Software Proficiency - Advanced experience using Microsoft Office tools (Word, Excel, PowerPoint, Project). - SolidWorks proficiency required; familiarity with FEA and GD&T is a must. Qualifications - Bachelor's degree in Mechanical Engineering or equivalent engineering discipline - 7+ years' mechanical design and manufacturing experience of which 5+ years of actual product development experience bringing innovative product to market from conception to launch in regulated industry. (Preference is given to medical device development).