Senior Mechanical Engineer

Located in Fairfield County, we work with cutting-edge Swiss machining, laser cutting, and 5-axis milling technology to create precision components used in life-changing medical devices. If you're looking for a team-oriented environment where you can make an impact with every part you produce, we want to hear from you!Position OverviewWe are seeking a Senior Mechanical Engineer to lead mechanical design and product development for medical manufacturing projects. The role focuses on delivering robust, manufacturable products and automation solutions using CAD and SolidWorks, ensuring compliance with medical device standards, and guiding cross-functional teams from concept through production.Key ResponsibilitiesLead mechanical design activities for medical device and manufacturing automation projects, from concept through production release.Create detailed CAD models, assemblies, and manufacturing drawings using SolidWorks and other CAD tools.Develop automation design solutions, including actuators, fixtures, sensors, and control interfaces to improve manufacturing efficiency and quality.Apply Design for Manufacturability (DFM) and Design for Assembly (DFA) principles to reduce cost and simplify production.Prepare and maintain engineering documentation, including specifications, bills of materials, and design verification/validation plans.Perform tolerance analysis, GD&T application, and risk assessments (e.g., DFMEA) to ensure product reliability and safety.Prototype, test, and iterate designs; collaborate with test engineers to define and execute verification protocols.Collaborate closely with manufacturing, quality, supply chain, and regulatory teams to support design transfer and supplier selection.Mentor junior engineers, provide technical guidance, and review design work to maintain engineering standards.Support regulatory submissions and design history files in compliance with ISO 13485 and FDA requirements where applicable.QualificationsBachelor's or Master's degree in Mechanical Engineering or related discipline.5+ years of hands-on mechanical design experience, preferably in medical manufacturing or similarProficiency with SolidWorks and CAD software; strong modeling, surfacing, and drawing skills.Experience designing automation systems, fixtures, and tooling for production environments.Solid understanding of GD&T, tolerance analysis, and engineering best practices.Familiarity with medical device regulations and quality systems (ISO 13485, FDA 21 CFR) is strongly preferred.Experience with prototyping, testing, and design verification/validation processes.Strong problem-solving skills, attention to detail, and ability to manage multiple projects and priorities.Excellent communication and collaboration skills; experience mentoring and leading engineering teams.Willingness to support supplier visits and occasional travel as needed.BenefitsCompetitive Salary $110,000 - $120,000Full Medical Insurance Short-Term Disability and Long-Term DisabilityLife InsurancePaid Vacation Days ( You deserve a break!!)Paid Holidays401k