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Position – Mechanical Design Engineer- Medical Devices
Location – Hyderabad, Telangana
- Be part of an extended R&D team and provide engineering support for design, development or optimization of products, processes, tooling and/or equipment by collaborating with the necessary stakeholders. Prepare necessary component /assembly drawings by following ASME guidelines and assist in release of the same in the PLM systems. Support sustaining/release product engineering tasks and activities by ensuring compliance with applicable procedures. Should maintain accountability and successfully deliver projects/tasks assigned. Ensure the design meets the product requirements for safety, reliability and manufacturability. Must learn and ensure compliance with all GBU design control processes and procedures.
PRINCIPAL WORKING RELATIONSHIPS
- Global (US) project stakeholders & Sr. Engg. Supervisor (MEIC). Possible interactions with third-party vendors, manufacturers, subcontractors, clinicians and other users.
EXPERIENCE & EDUCATION
- Bachelor’s Degree in Mechanical Engineering or equivalent with 5 to 8 years of Product design experience.
KNOWLEDGE AND SKILLS
- In-depth experience in CAD tools such as Pro-E Creo/Solid works is expected.
- Expertise in Robust Modeling and Detailing practices following the ASME guidelines.
- Knowledge and application of GD&T including Tolerance stack-up analysis.
- Strong knowledge of metal and plastic component manufacturing processes.
- Knowledge on Engineering Change management processes and PLM tools such as Agile, PTC Windchill is preferred.
- Good understanding of medical device standards , guidelines and regulations per ISO 13485, ISO 14971 and Design controls ( 21 CFR Part 820).
- Able to effectively work with cross functional teams in a multinational matrix organization.
- Superior written and verbal communication skills required.
- Good attitude and team player.
Skills & Experience
- Creo, FDA Medical Device Regulations, ISO 13485 Medical Devices, SolidWorks
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