Job Description A degree level or similar qualification in mechanical, industrial, or packaging engineering. Minimum 5 years of hands‑on experience in medical device quality systems in various operational tasks. Knowledgeable in FDA, MDD, and MDR GMP requirements for medical devices. Experience leading cross‑functional teams is required. Change management in regulated operational environments (ERP & PLM systems) is preferred. Bachelor of Computer Science (additional educational requirement). Roles & Responsibilities Support the Packaging department and finalize validation activities. Perform DDL functions for Windchill and SAP tasks. Update Packaging work instructions. Create or update process and inspection sheets. Participate in Pack/Label and MD systems deployment; be trained on new systems to support day‑to‑day activities. Execute safety upgrades, validation, and calibration. Handle ERP change tasks. Manage tool crib consumables import into Windchill – partner with vendors. Provide Windchill FIA support. Update workflow/router in SAP. Offer process/manufacturing engineering support. Assist with process training support. Salary Range $90,000 – $95,000 a year TCS Employee Benefits Summary Discretionary Annual Incentive. Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans. Family Support: Maternal & Parental Leaves. Insurance Options: Auto & Home Insurance, Identity Theft Protection. Convenience & Professional Growth: Commuter Benefits & Certification & Training Reimbursement. Time Off: Vacation, Time Off, Sick Leave & Holidays. Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing. #J-18808-Ljbffr
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