Jobility

Job Title: Principal Mechanical Engineer Location: Raleigh, NC Duration: 3 months Job Summary The Principal Mechanical Engineer will develop new products, redesign existing products, and perform research and testing on product concepts for medical devices. This individual will support research, development, and commercialization of medical devices aligned with business objectives. The role spans concept development, design, verification testing, and transfer to manufacturing. Candidates must have medical device industry experience and be familiar with regulatory and quality requirements throughout the product development lifecycle. Responsibilities: Technical Lead Provide technical leadership on system features and functions for medical devices. Collaborate with and lead cross-functional engineering teams. Mechanical Engineering Lead development projects and manage assigned team members to ensure on-time progress. Conduct engineering analyses, feasibility studies, and support advanced development efforts. Provide broad mechanical engineering expertise across all product lifecycle phases. Innovation Design, develop, and test innovative concepts to support clinical, patient, and business needs. Collaborate with engineering and marketing teams on product feasibility evaluations. Serve as a subject matter expert for designing and building test setups and fixtures. Documentation Maintain accurate documentation in accordance with GDP and GMP. Write product requirements and specifications. Plan, design, execute, and report system experiments for feature development and roadmap activities. Test Methods Develop test plans, validate designs, run performance calculations, and approve prototypes. Validate test tools and setups as needed. Prototype Manufacturing Lead prototype builds, create BOMs, order materials, and train lab technicians. Work with manufacturing and operations teams to develop device build processes. Operate key lab equipment (oscilloscope, microscope, acoustic tank, force balance, translation stage, impedance analyzer, pulse-echo fixture, cryostats). Conduct PCBA testing and soldering. Maintain strong laboratory practice standards. Essential SkillsLead Self Time Management Digital Acumen Problem Solving Emotional Intelligence Resiliency Communication Lead Others Leadership Collaboration Project Management Motivation & Influence Technical & Functional Skills Deep knowledge of test method validation, GR&R, GD&T, and statistical analysis SolidWorks or similar CAD expertise Understanding of ISO Quality Systems and FDA medical device regulations Familiarity with mechanical and electromechanical manufacturing processes Minimum Qualifications Bachelor's degree in Mechanical, Industrial, Electrical, or related engineering field 10+ years of mechanical design/manufacturing experience in medical devices or related fields Experience with Design Controls and process verification/validation Experience with manufacturing and assembly process validation (IQ, OQ, PQ) Knowledge of injection molding, die casting, metal stamping, machining processes Experience with fixtures, gauges, and tooling design Preferred Qualifications Six Sigma or SPC knowledge; Green or Black Belt preferred Experience with project management tools and methodologies Travel Requirements Up to 20% Physical Requirements Ability to sit, stand, lift up to 25 lbs, and perform general office and lab tasks Frequent bending, stooping, and reaching