Mechanical Design Engineer

1 week ago

Madurai, India Aurolab Full time

Job Summary:

We are looking for a talented and motivated Mechanical Design Engineer to join our New Product Development (NPD) team for medical device development. The ideal candidate will have 3-5 years of experience in mechanical design, with strong proficiency in 3D modelling, specifically using SolidWorks along with Ansys or Hypermesh. Previous experience in the medical device industry is a plus, but not mandatory. The role will focus on the design, development, and optimization of innovative medical devices from concept through production.

Key Responsibilities:

Mechanical Design & Development:

- Lead mechanical design efforts for electromechanical medical devices throughout the product lifecycle.
- Design and develop mechanical components, assemblies, and systems for new medical devices.
- Create detailed 3D models, drawings using SolidWorks along with Ansys or Hypermesh and create product specifications, adhering to medical device industry standards.
- Perform design calculations and simulations to ensure product reliability, safety, and functionality.

Collaboration & Cross-functional Support:

- Work closely with the NPD team, including electrical engineers, regulatory teams, and quality assurance, to ensure cohesive product development.
- Collaborate with manufacturing teams to support design for manufacturability (DFM) and assembly (DFA) principles.

Prototyping & Testing:

- Lead or support prototype development and testing, including hands-on assembly and troubleshooting of mechanical prototypes.
- Interpret test results and iterate designs based on feedback and testing data.

Compliance & Documentation:

- Ensure all designs meet regulatory and quality standards required for medical devices (e.g., ISO 13485, FDA guidelines).
- Document design changes and maintain comprehensive design history files.

Continuous Improvement:

- Identify areas for design improvement, cost reduction, and process optimization.
- Stay current with new technologies, design techniques, and medical device trends.

Qualifications:

Education:

- Bachelor’s degree in Mechanical Engineering or a related field.

Experience:

- 3-5 years of hands-on experience in mechanical design, preferably in the medical device or similar highly regulated industries.
- Proficiency in 3D CAD modelling, 2D detail drawings specifically SolidWorks.
- Hands on experience in Sheet metal, Machine design and Manufacturing feasibility analysis.
- Familiarity with design and manufacturing processes, including prototyping, Design verification testing, and validation.

Skills & Competencies:

- Strong understanding of mechanical design principles, materials, and manufacturing processes.
- Good knowledge of product development life cycle, especially in the context of medical devices.
- Sound knowledge of GD&T, Experience in BOM (Bill of Material) structures
- Ability to work independently and in a team environment.
- Excellent problem-solving skills and attention to detail.
- Strong communication skills, both written and verbal.

Preferred:

- Experience in leading and designing for medical devices or healthcare products.
- Familiarity with regulatory requirements for medical device development (FDA, ISO 13485, etc.).
- Experience with design documentation and change control design control in a regulated environment.

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