Job Description
About the job:
Job Summary:
As a Mechanical Engineer at InspireMD you will be responsible for improving and developing the production processes, as well as designing mechanical components for our medical devices. You will work closely with cross-functional teams to ensure that our products meet the highest standards of performance, safety, and regulatory compliance.
Essential Duties and Responsibilities
- Develop and improve production processes to enhance efficiency, quality, and scalability of medical device manufacturing.
- Design and create jigs, fixtures, and tooling to support assembly, testing, and quality control processes.
- Design and develop mechanical components and assemblies for medical devices.
- Lead implementation of engineering change orders (ECOs) impacting the product, production line and supplier processes.
- Collaborate with manufacturing and assembly teams to troubleshoot and resolve production issues, optimizing designs for manufacturability and ease of assembly.
- Support the transition from prototype to production.
- Create and review detailed engineering drawings, specifications, and documentation in compliance with industry standards and regulatory requirements.
- Prototype and test new designs, analyze test data, and iterate on designs based on test results and feedback.
- Participate in design reviews, risk assessments, and continuous improvement initiatives.
Requirements (Relevant Education/ Languages, Skills)
- Bachelor’s degree in mechanical engineering or a related field.
- 3-5 years of experience in mechanical engineering, with a focus on medical devices or similar regulated industries.
- Proficiency in CAD software (e.g., SolidWorks, AutoCAD) and engineering analysis tools.
- Strong understanding of material properties, manufacturing processes, and mechanical design principles.
- Experience with design for manufacturability (DFM), design for assembly (DFA), and design verification and validation (V&V).
- Strong understanding of Quality Management Systems (QMS)
- Familiarity with medical device regulations and standards (e.g., FDA, ISO 13485).
- Excellent problem-solving skills, attention to detail, and ability to work effectively in a team environment.
- Strong communication skills, both written and verbal.
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