Manufacturing Engineer

• Support all phases of Operations MDD/MDR product MDD/MDRTF remediation.
• Operations Supplier (CM/OEM) and continuity engineering tasks
• Design manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining, and material handling.
• Review of inspection and test requirements within production plans requiring remediation
• Initiate corrective action of problems and deficiencies to ensure process and/or product quality as required
• Need help supporting NCMRs, Paper IFUs (versioning capital, IFU kits MATNRs), PCRs, PCHs, Work Instructions Updates, CAPAS/Corrective Actions from NCMRs, PPAP, providing manufacturing technical support to SQEs, Supplier Process Improvement, Reporting (Pareto NCMRs, trending and insights/Help needed), PCR - Product EOL PCR, Product replacement PCR.
• Control plan review, Inspection Criteria creation, QAC Creation, ECO & SMECO Approval, DCO routing
• Driving supplier quality performance, including new product development and product quality improvement.
• Qualifies suppliers according to Supplier standards (PPAP
  - Production Part Approval Process) and may administer a Certified Supplier Program in receiving inspection
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation
• Works with supplier to obtain each deliverable according to the PPAP procedure and evaluate adequacy to the requirements
• PFMEA, Process controls, MSA, Supplier Validation (IQ/OQ/PQ), Process Capability
• Providing leadership and management for the supplier quality department.
• Overseeing supplier quality team and establishing quality control objectives
• Work with R&D and Contract Manufacturer to create Bill of Materials (BOM)
• Work with R&D and Contract Manufacturer to create subcomponent specifications
• Create Test Method Validations (TMV)
• Implement Acceptance Activities for subcomponents
• Implement Quality Agreements
• Collaboration with different functions, Supplier communication
• Understand qualification requirement/process, knowledge of quality agreements

Salary Range: $80,000 - $86,000 a year

• Discretionary Annual Incentive.
• Compr ehensive 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.

#LI-DNI

Memphis, TN

TECHNOLOGY

434680

Manufacturing Engineering | Medical Device NPD