Mechanical Engineer

Senior Mechanical EngineerTo work from their South Maine office/production facility. The position reports to the Director of Engineering and Production and will focus on developing new designs and processes for advanced optics assemblies and systems for the biomedical market. The ideal candidate will be self-motivated with a passion for learning and staying current in their field, and will be excited to grow and shape the role in an innovative environment.Permanent Location: South MaineUS Citizen or Green Card holders onlyDrive the conceptualization and detailed design of complex optomechanical systems using 3D CAD.Perform advanced engineering analyses (FEA, CFD) and tolerance analysis (GD&T) to optimize designs for performance and manufacturability.Serve as a key technical point of contact for customers, translating complex requirements into robust engineering specifications.Manage the full prototyping lifecycle, from vendor management to hands-on assembly, integration, and alignment.Lead root cause analysis to solve complex challenges related to system performance, assembly, and manufacturability.Develop and execute comprehensive verification and validation (V&V) test plans to ensure product reliability and performance.Generate detailed technical reports and ensure all design activities and documentation comply with ISO 13485 standards.Provide critical engineering support during the design transfer to manufacturing, applying DFM/DFA principles.Select and qualify advanced materials and manufacturing processes suitable for medical device applications.Mentor junior engineers and provide technical guidance to cross-functional project teams.Education: Bachelor's degree in Mechanical Engineering (Master's degree preferred).Experience: Experience in mechanical design and development, preferably in optics, photonics, or a related industry.Skills and Abilities:Requires a Bachelor's degree in Mechanical Engineering (or a related field) and product development experience, with medical device industry.Expert-level proficiency in 3D CAD (SolidWorks preferred), with extensive experience in complex assemblies and advanced modeling techniques.Deep expertise in core mechanical design principles (stress analysis, heat transfer, vibration) and mastery of GD&T (ASME Y14.5) for tolerance analysis.Strong background in various manufacturing processes and experience using advanced engineering simulation tools to validate and optimize designs.Proven experience with ISO 13485, FDA design control regulations, and risk management standards (ISO 14971) within a Quality Management System.Demonstrated ability to lead major design efforts from initial concept through to successful product launch in a highly regulated environment.