Job Description

-------------------

Seeking a detail-oriented and analytical

Design & Validation Engineer

with expertise in

CAD tools (SolidWorks)

,

statistical analysis (Minitab)

, and

risk management methodologies

. The ideal candidate will be responsible for supporting the design, development, and validation of engineering solutions with a strong focus on

usability

,

reliability

, and

compliance

with safety and quality standards.

Key Responsibilities:

Develop and modify 3D models and 2D drawings using

SolidWorks

and other CAD tools.

Conduct

design validation

,

reliability testing

, and

usability assessments

for new and existing products.

Perform

statistical analysis

using

Minitab

to support data-driven decision-making in design and testing.

Lead and document

Risk Hazard Analysis

,

Use FMEA

, and

Design FMEA

activities.

Create and maintain

Design & Development Plans

in alignment with project and regulatory requirements.

Collaborate with cross-functional teams including R&D, quality, and manufacturing to ensure robust product development.

Support

impact analysis

,

document routing

, and

risk mitigation planning

throughout the product lifecycle.

Required Skills & Qualifications:

Bachelor's degree in Mechanical Engineering, Industrial Engineering, or a related field.

4-8 years of experience in

engineering design

,

risk analysis

, and

product validation

.

Proficiency in

SolidWorks

and

computer-aided engineering (CAE)

tools.

Strong knowledge of

Minitab

or equivalent statistical software.

Experience with

FMEA

,

risk management

, and

design control documentation

.

Solid understanding of

materials

,

manufacturing processes

, and

engineering principles

.

Excellent communication and documentation skills.

Preferred Qualifications:

Experience in

medical devices

,

automotive

, or

aerospace

industries.

Familiarity with

ISO 14971

,

IEC 60601

, or other relevant regulatory standards.

*

Knowledge of

DOE (Design of Experiments)

and

Six Sigma

methodologies.