Mechanical Engineer

Job Description

The Mechanical Engineer will be responsible for optimizing and developing production processes, as well as designing mechanical components for medical devices. This role will involve close collaboration with cross-functional teams to ensure that products meet the highest standards of performance, safety, and regulatory compliance.

Responsibilities:

• Process Improvement: Enhance the efficiency, quality, and scalability of medical device manufacturing by developing and refining production processes.
• Tooling Design: Create jigs, fixtures, and tooling to support assembly, testing, and quality control processes.
• Component Design: Design and develop mechanical components and assemblies for medical devices.
• Change Management: Lead the implementation of engineering change orders (ECOs) impacting the product, production line, and supplier processes.
• Manufacturing Support: Collaborate with manufacturing and assembly teams to troubleshoot and resolve production issues, optimizing designs for manufacturability and ease of assembly.
• Product Transition: Support the transition of new products from prototype to production.
• Documentation: Create and review detailed engineering drawings, specifications, and documentation in compliance with industry standards and regulatory requirements.
• Design Iteration: Prototype and test new designs, analyze test data, and iterate on designs based on test results and feedback.
• Continuous Improvement: Participate in design reviews, risk assessments, and continuous improvement initiatives.

Requirements:

• Education: Bachelor’s degree in mechanical engineering or a related field.
• Experience: 3-5 years of experience in mechanical engineering, with a focus on medical devices or similar regulated industries.
• Technical Skills: Proficiency in CAD software (e.g., SolidWorks, AutoCAD) and engineering analysis tools.
• Knowledge: Strong understanding of material properties, manufacturing processes, and mechanical design principles.
• Experience: Experience with design for manufacturability (DFM), design for assembly (DFA), and design verification and validation (V&V).
• Quality Systems: Strong understanding of Quality Management Systems (QMS).
• Regulatory Compliance: Familiarity with medical device regulations and standards (e.g., FDA, ISO 13485).
• Soft Skills: Excellent problem-solving skills, attention to detail, and ability to work effectively in a team environment. Strong communication skills, both written and verbal.