Manufacturing Engineer

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.

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 & 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-DNI

Desired Candidate Profile