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Mechanical Design Engineer
4 weeks ago
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.
