Senior Design Engineer

What you will do:

• Own engineering change management, including impact assessment, documentation, approvals, and implementation across stakeholders.
• Lead the design and development of mechanical components and systems for medical devices and execute end-to-end product development (NPD) across lifecycle phases—from concept through design, validation, and product launch.
• Translate user and clinical needs into engineering requirements, specifications, and system-level designs and perform engineering analysis including simulations, and statistical evaluations to optimize design performance.
• Develop and maintain technical documentation such as Design History Files (DHF), Device Master Records (DMR), drawings, labeling, and IFUs.
• Collaborate with lab teams to plan and execute verification & validation (V&V) activities, including test method development and reporting and partner cross-functionally with R&D, Quality, Manufacturing, Regulatory, Clinical, and Marketing teams to deliver projects within scope, quality, cost, and timelines.
• Lead or contribute to technical discussions with global stakeholders, vendors, and SMEs.
• Apply and enforce design controls, risk management, NC/CAPA processes, and regulatory compliance practices.
• Mentor team members and provide technical leadership in design, analysis, and problem-solving for complex systems and subsystems.
• Support Voice of Customer (VoC) initiatives and integrate clinical insights into product designs and identify and implement process improvements, new tools, and technologies to enhance product development efficiency.
• Analyze and resolve complex design issues, ensuring robust, manufacturable, and reliable solutions.

What You Will Need:

Required Skills:

• Bachelor of Science in Mechanical Engineering or Master’s in mechanical
• Experience- 5 years -7 years
• Expertise in CAD tools (Creo/SolidWorks/UG) with hands-on experience in modeling, drafting, and GD&T application; electromechanical systems , enclosures, sheet metal, and plastic part design.
• Proficiency in design for manufacturing & assembly (DFM/DFA), materials selection, and manufacturing processes and knowledge of thermal analysis/simulation and Experience engineering calculation work methods.
• Understanding of engineering change processes, including ECN/ECO creation and implementation.

Preferred Qualifications :

• Familiarity with statistical tools (e.g., Minitab), process capability analysis, and DOE methodologies.
• Strong problem-solving and analytical skills, with demonstrated ability to resolve complex engineering challenges.
• Exposure to highly regulated environments (e.g., medical devices, aerospace, automotive) is highly desirable.