Mechanical Design Engineer

Job Summary:

3-5

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.