Medical Device Manufacturing Engineer
5 days ago
We are seeking a highly skilled Medical Device Manufacturing Engineer to join our team at IBU Consulting Pvt Ltd. As a key member of our engineering team, you will be responsible for developing and optimizing efficient manufacturing processes for medical devices.
Key Responsibilities:
- Develop and optimize manufacturing processes for medical devices, focusing on capital and/or disposable devices.
- Produce production-level assembly and part drawings for all components and sub-assemblies.
- Incorporate Design for Manufacturing (DFM), Six Sigma, and LEAN principles into product and process designs.
- Proactively identify and evaluate potential contract manufacturing partners.
- Lead and collaborate with contract manufacturers in selecting and developing manufacturing processes and sites.
- Act as a liaison between Contract Manufacturing Organization (CMO) and Canon to coordinate manufacturing activities.
- Review engineering product specifications and CAD data/drawings to ensure they meet industry and manufacturing standards.
- Responsible for part/drawing release and the accuracy of the Bill of Materials (BOM).
- Drive the development and execution of complex experiments and tests to qualify and validate manufacturing processes.
- Responsible for Characterization and Validation activities, including CTQ flow-down and identification of critical control points.
- Deploy manufacturing risk assessment and mitigations.
- Develop and maintain manufacturing work instructions, equipment instructions, and other documents.
- Coordinate technical communications between Canon and contract manufacturers.
- Provide technical expertise in conducting pFMEA and developing process validations.
- Share expertise in Lean Six Sigma process excellence principles.
Qualifications:
- Bachelor's degree or higher in Mechanical engineering.
- 5+ years of experience in medical device manufacturing engineering, including new product development, design transfer to production, and validating processes.
- Excellent modeling and drawing skills using SolidWorks.
- Experience working with contract manufacturers/vendors for capital equipment, electronics testing, and/or catheter manufacturing is strongly preferred.
- Proven track record in design transfer, process validation, and knowledge of sterilizable polymers and catheter fabrication techniques.
- Technical expertise in DFM, Six Sigma, LEAN, cGMP, and process validation.
- Proficient in SolidWorks with experience in tool and fixture design.
- Highly proficient in Microsoft Office Suite and statistical analysis software like Minitab or JMP.
Nice to Haves:
- Lean and/or Six Sigma certifications preferred.
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