Source description
About the role
Must Have Technical/Functional Skills
• A degree level or similar qualification in mechanical or industrial or packaging engineering.
• Minimum 5 years of hands-on experience in medical device quality systems in various operational tasks of quality systems
• Knowledgeable in medical device FDA, MDD and MDR GMP requirements.
• Experience leading cross-functional teams is required
• Change management in regulated operational environments is preferred (ERP & PLM systems)
Roles & Responsibilities
• Support Packaging department and finalize validation activities
• DDL function for Windchill/SAP tasks
• Updating Packaging work instructions
• Create/Update Process sheets/inspection sheets
• Participate in Pack /Label and MD systems deployment and be trained on new system to be able to support day-to-day activities
• Safety upgrade, validation and calibration
• ERP change tasks
• Tool crib consumables inload in windchill - partner with vendors
• Windchill FIA support
• Workflow /Router updates in SAP
• Process/manufacturing engineering support
• 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 & amp; Training Reimbursement.
Time Off: Vacation, Time Off, Sick Leave & Holidays.
Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.
#LI-SP1
Role: Engineer
Desired skills: PLM | Windchill
Qualifications: BACHELOR OF COMPUTER SCIENCE
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Experience: 5 - 15 Years
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Job function: TECHNOLOGY
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Location: Raynham, MA
Salary range: $90,000–$95,000
Apply by: 2026-08-08 00:00:00
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