Sr R/D Engineer
As a member of MEIC Restorative therapies group (RTG) you will collaborate closely with all the necessary stakeholders on the assigned tasks including your counterparts in the US to ensure timely and successful completion of the same.
A Day in the Life
• 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.
• Lead design reviews with cross functional team to ensure the design meets the product requirements for safety, reliability and manufacturability.
• 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.
• Assist in the preparation of Product Risk Management documents (DFMEA, Memo, report) along with Quality Engineering team.
• Assist in creation of necessary DHF documentation along with relevant project stakeholders to ensure timely completion and release per project schedules.
• Prepare reports, presentations and spreadsheets of an analytical and interpretative nature to be presented to peers, executives, customers.
• Must learn and ensure compliance with all GBU design control processes and procedures.
• Incorporate required regulatory standards (FDA, ISO) in developmental and/or sustaining engineering projects including written protocols, test methods, assembly processes and the design history file.
• Should maintain accountability and successfully deliver projects/tasks assigned.
• Assist fellow team members by coaching, mentoring and reviewing team deliverables whenever necessary to ensure timely completion of project milestones.
• Ability to lead the project independently through milestones / stage gate exits towards successful closure with minimal or no supervision.
Must Have / Minimum Qualification
• Bachelor’s Degree in Mechanical Engineering or equivalent with 8 to 12 years of Product Development experience.
• 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.
• Strong Knowledge and application of GD&T including Tolerance stack-up analysis.
• Strong knowledge of metal manufacturing processes. Knowledge on 3D printing and additive manufacturing technologies is an add-on.
• Knowledge on Engineering Change management processes and PLM tools such as Agile, PTC Windchill is preferred.
• Strong understanding of medical device standards , guidelines and regulations per ISO 13485, ISO 14971 and Design controls ( 21 CFR Part 820).
• Ability to create, assess or review applicable product DHF deliverables such as Risk files, Sterilization reports, Bio-compatibility reports etc. along with support from relevant project stakeholders.
• Strong knowledge of Engineering fundamentals and application of same during concept generation or re-design of products.
• Able to effectively work with cross functional teams in a multinational matrix organization.
• Must have inclination towards coaching or mentoring the team technically (hands on).
• Superior written and verbal communication skills required.
• Good attitude and team player.
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