Senior Mechanical Design Engineer

We are looking for a skilled and motivated Medical Device Mechanical Engineer to join our R&D/Engineering team. The candidate will be responsible for the mechanical design, development, prototyping, testing, verification, and documentation of medical devices and their components.

The ideal candidate should have strong knowledge of mechanical design principles, 3D CAD, materials, manufacturing processes, tolerance analysis, and product development, along with an understanding of medical-device quality and regulatory requirements.

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 SolidWorks, 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 assembly
• GD&T and tolerance analysis
• Root-cause analysis and problem solving
• Verification and validation
• Risk-based engineering
• Cross-functional collaboration
• Attention to detail
• Technical documentation

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"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans. xhyhwjd "

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 View phone number on techcareers.com or send me email on

Regards

Niraj kumar