Job Information
Tata Elxsi Mechatronics Engineer in Troy, Michigan
Company: Tata Elxsi Limited
Position Title: Mechatronics Engineer
Location: 2701 Troy Center Drive, Troy, MI 48084
and unanticipated client locations throughout the U.S.
Job description: Work with core team to obtain and track documents for contract manufacturers and multiple Medtronic business unit design and manufacturing sites as applicable. Develop an understanding of products, customer codes and validation procedures. Conduct gap assessment and analyze the findings in alignment with the EU Medical Device Regulations. Create gap assessment and support Medtronic approval process for document changes. Support notified body submission, review feedback incorporation and audits as applicable. Implement the final label for all customer facing numbers and global trade identification numbers (GTINs) post approval by Notified Bodies. Facilitate Onsite label print testing at design site and production printing at manufacturing site. cross-functional collaboration with Subject Matter Expert (SME) for deliverables. Conduct Root Cause Analysis and brain-storming sessions with team to address any defects identified and implement new processes for efficiency. Create and update dashboards, trackers using project management tool. Provide cross training of team members and monitor progress.
Job requirements: Master's degree (or foreign equivalent) in Mechanical Engineering, Electronics Engineering, Engineering (any), or a related field, PLUS two (2) years of experience in the job offered or a related position. Experience must include demonstrable knowledge of: MS Project; Smartsheet; MS Office; Adobe Illustrator; Adobe InDesign; Adobe Photoshop; Prisym Medica; Prisym 360; Agile PLM; Zebra printers; Intermek/Honeywell printers; EU MDR, ISO 15223-1; MDD; EU and US UDI; EUDAMED; EN 1041/ISO20417; ISO 13485; ISO 14971; UKCA; US FDA, and; GS1 Barcode. Travel to unanticipated client locations approximately 30%, as required. May telecommute from any location within the U.S. Multiple positions available.
Please send resume to nirbhayd@tataelxsi.com. Reference job code 57901.0164