Manufacturing Engineer

Job Title

Must Have Technical/Functional Skills

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

Tech File review

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.

Roles & Responsibilities

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 Risk documents for subcomponents

Create Test Method Validations (TMV)

Qualify/validate subcomponents

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

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.

Location: Memphis, TN

Function: TECHNOLOGY

Role: Engineer

Skills: Manufacturing Engineering | Medical Device NPD