Medical Device Manufacturing Engineer
2 weeks ago
We are seeking a highly skilled Medical Device Senior Manufacturing Engineer to join our team at RaiZan Solutions. As a key member of our engineering team, you will play a critical role in developing and optimizing efficient, cost-effective manufacturing processes for cutting-edge medical devices.
Key Responsibilities- Develop and optimize validated manufacturing processes for medical devices, focusing on both capital and disposable devices (assembly, testing, sterilization, packaging).
- Create production-level assembly and part drawings for components and sub-assemblies using SolidWorks.
- Apply Design for Manufacturing (DFM), Six Sigma, and LEAN principles to ensure efficient, cost-effective production.
- Collaborate with contract manufacturers to select and develop reliable manufacturing processes, ensuring regulatory compliance.
- Act as a liaison between Contract Manufacturing Organizations (CMOs) and internal teams to coordinate and streamline production activities.
- Review engineering product specifications and CAD drawings to meet industry standards.
- Lead the development and execution of complex experiments and tests to qualify and validate manufacturing processes.
- Conduct characterization and validation activities, identifying critical control points within the manufacturing process.
- Maintain and develop manufacturing work instructions, BOMs, pFMEA, and other quality management system documents.
- Maintain up-to-date BOMs, work instructions, and travelers.
- Lead and maintain DFM activities, process validation, and quality improvement initiatives.
- Implement pFMEA and ensure optimal manufacturing efficiency.
- Bachelor's degree (or higher) in Mechanical Engineering.
- 5+ years of experience in medical device manufacturing engineering, with at least 3 years in new product development and design transfer.
- Hands-on experience with cart systems, console operations, and electromechanical devices, including troubleshooting and optimization.
- Proficiency in SolidWorks, including complex assembly modeling and drawing.
- Experience working with contract manufacturers on capital equipment, electronics testing, or catheter manufacturing.
- Knowledge of sterilizable polymers and catheter fabrication techniques.
- Expertise in DFM, Six Sigma, LEAN, cGMP, and process validation.
- Proficient in Microsoft Office Suite and statistical analysis software (e.g., Minitab or JMP).
- An opportunity to work on impactful medical device projects in a collaborative and supportive environment.
- Exposure to cutting-edge technologies and innovative manufacturing techniques.
- Competitive compensation and career development opportunities within a Fortune 500 company.
- A culture that values diversity, inclusion, and career growth.
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