16 Aug
|
Stryker
|
Gurugram
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 identify and implement process improvements, recent 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; electro
📌 Senior Design Engineer (Gurugram)
🏢 Stryker
📍 Gurugram