Job Title

Job Summary: We are looking for a talented and motivated Senior Mechanical Design Engineer to join our New Product Development (NPD) team for medical device development. The ideal candidate will have 8-12 years of experience in mechanical design, with strong proficiency in 3D modelling, specifically using SolidWorks. 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 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: 8-12 yearsof 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.