Prin R-D Engineer
• 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 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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