Senior Mechanical Design Engineer

Key Responsibilities: Design and develop mechanical components, assemblies, mechanisms, enclosures, and fixtures for medical devices. Create and maintain 3D CAD models, 2D engineering drawings, BOMs, and design documentation. Apply GD&T, tolerance stack-up, material selection, and DFM/DFA principles. Develop prototypes and coordinate fabrication, assembly, and design iterations. Perform mechanical calculations, tolerance analysis, and basic structural/FEA analysis as required. Plan and execute mechanical verification and validation testing. Evaluate product performance, reliability, durability, and mechanical safety. Conduct design reviews and support root-cause analysis and corrective actions. Work closely with electrical, software, manufacturing, quality, regulatory, and clinical teams during product development. Support design transfer and transition of products from R&D to manufacturing. Identify and resolve design, manufacturing, and assembly issues during development and production. Prepare engineering documentation including design inputs, design outputs, test protocols, test reports, risk-management inputs, and engineering change documentation. Support product risk assessments and failure-mode analysis. Ensure designs comply with applicable company procedures, standards, and medical-device regulatory requirements. Participate in supplier evaluation, component qualification, and technical discussions with vendors.

Required Qualifications: Bachelor's degree in Mechanical Engineering, Mechatronics, Biomedical Engineering, or a related discipline.2–6 years of experience in mechanical product design and development; experience in medical devices is preferred. Strong hands-on experience with Solid Works, Creo, NX, CATIA, or equivalent CAD software. Good understanding of GD&T, tolerance analysis, materials, and manufacturing processes. Experience with prototyping, mechanical testing, and design verification. Good understanding of plastics, metals, machining, injection molding, sheet metal, and/or additive manufacturing. Ability to read and interpret engineering drawings and specifications. Strong problem-solving and analytical skills. Good written and verbal communication skills.

Preferred Qualifications: Experience developing regulated medical devices or healthcare products. Knowledge of ISO 13485 and ISO 14971.Familiarity with FDA/21 CFR Part 820 or other applicable medical-device regulations. Experience with design controls, risk management, V&V, and design-transfer activities. Experience with FEA, tolerance stack-up analysis, or reliability engineering. Experience working with contract manufacturers and external suppliers.

Key Competencies: Mechanical design and engineering fundamentals Product development and prototyping Design for manufacturability and assemblyGD&T and tolerance analysis Root-cause analysis and problem solving Verification and validation Risk-based engineering Cross-functional collaboration Attention to detail Technical documentation“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”If you are inclined, I would be happy to set up some time to chat more about your background and career interests to see if there could be a possible match. Please feel free to call me on 732-806-7467 or send me email on nirajk@mindlance.com Regards Niraj kumar