Senior Design Engineer
Top focus
Work Flexibility: Hybrid 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 id entify 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.
- Travel Percentage: 20%