Senior Mechanical Design Engineer

Ilensys Technologies; Hyderabad; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Ilensys Technologies in Hyderabad seeks a Senior Mechanical Design Engineer to lead injection-molded plastic designs, DFM/DFA optimization, tooling interaction, material selection, and high-volume manufacturing initiatives. Hands-on CAD (SolidWorks or Creo) with GD&T and tolerance stack-up, drawings and BOM management, and rigorous ECO/change control.

Experience in regulated medical/life sciences settings (ISO 13485, 21 CFR, GMP/QMS) with DHF/traceability, V&V ownership (DVP/DVP&R), and

Qualifications

• Strong injection-molded plastic design with DFM/DFA, tooling interaction, material selection, and high-volume manufacture.
• Hands-on CAD proficiency (SolidWorks/Creo) with GD&T and tolerance stack-up, drawings, BOM management, and ECO processes.
• Experience in regulated environments (medical/life sciences) with ISO 13485, 21 CFR, GMP/QMS and design controls (DHF, traceability).
• Ownership of V&V activities including DVP/DVP&R, test protocol execution, and design verification/validation.
• Analytical and statistical capability (MSA/ SPC / Gage R&R) and data-driven problem solving with Minitab.
• Cross-functional collaboration and technical leadership; support mold/process validation (IQ/OQ/PQ, DOE).

Responsibilities

• Lead injection-molded plastic design projects with DFM/DFA and tooling liaison.
• Coordinate CAD work and ensure GD&T, drawings, and BOM accuracy.
• Ensure compliance with ISO 13485, 21 CFR, GMP/QMS; manage design controls (DHF, traceability).
• Own V&V activities including DVP/DVP&R and test protocol execution.
• Apply statistical methods (MSA, SPC; Gage R&R) for data-driven decisions.
• Mentor cross-functional teams and support mold/process validation (IQ/OQ/PQ, DOE).

Skills

Injection molding design

DFM/DFA

CAD: SolidWorks/Creo

GD&T

High-volume manufacturing

Tooling interaction

Material selection

Drawings & BOM

Regulated environments

ISO 13485

Tools

Minitab

Job description

Role & responsibilities

Role Senior Mechanical Design Engineer

Experience – 8 Yrs

• Strong injection-molded plastic design expertise, including DFM/DFA, tooling interaction, material selection, and high-volume manufacturing experience.
• Hands-on CAD proficiency (SolidWorks or Creo) with solid understanding of GD&T, tolerance stack-up, drawings, BOM management, and engineering change processes.
• Experience in regulated environments (medical/life sciences preferred) with knowledge of ISO 13485, 21 CFR, GMP/QMS, and design control processes (DHF, traceability).
• Verification & Validation ownership, including DVP/DVP&R development, test protocol execution, and design verification/validation activities.
• Strong analytical and statistical capability, including MSA, SPC, Gage R&R, DFSS, and data-driven problem-solving using tools like Minitab.
• Cross-functional collaboration and technical leadership, with sound engineering judgment and experience supporting mold/process validation (IQ/OQ/PQ, DOE preferred)