Manufacturing Engineering Support

The purpose of this position is to lead review and contribute to validation planning risk assessment system requirements formulation design specifications qualification protocol and remediation efforts. The person will act as a crossfunctional interbusiness unit resource. As such the incumbent must be technically competent in multiple disciplines including information technology quality and GxP processes.

Medical devices technical transfer experience

Creating maintaining and improving controlled technical documents such as prints procedures bill of materials and routers

Developing and supporting a wide variety of processing applications such as machining finishing forging casting cleaning heat treating bonding molding etc

Conducting feasibility study on advanced processes to estimate product cost and analyze capital equipment capacity and capability requirements

Establishing and improving process methods which meet performance and quality requirements

Developing leading and executing project plans and schedules for work activities

Communicating (written and verbal) direction and project plans with appropriate personnel from other departments

Evaluating multiple options to select the most appropriate processes and machining methods

Leading equipment qualification or process validation project(s)

Solving a variety of complex product and/or process performance issue

Developing rationale to set new process performance and quality standards Experience supporting medical device manufacturing

Specific experience with process characterization equipment IQ/OQ process OQ and PQ

Specific experience with Test method Validation and Gage R&R Experience with root cause analysis and problemsolving for both technical and process issues

Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISOAbility to lead and prioritize multiple mediumcomplexity project assignments and complete work in a timely manner

Good problemsolving skills through the use of quality and statistical tools

BOM & Router creation and update Ability to read and understand engineering drawings

Knowledge of basic quality tools risk analysis (PFMEA) statistics (SPC) Criticalto Quality (CTQ) Analysis

Knowledge of Quality System requirements ISO and FDA requirements Ability to effectively work within a crossfunctional team to complete critical project tasks

Demonstrates good written and verbal communication skills

Experienced with control procedures such as the Change Management System Nonconformance Reports Engineering Specifications Corrective and Preventive Action (CAPA) and Work Instructions & Proficient with Statistical Process Control concepts process development CNC programming terminology and tooling design concepts Microsoft Office Suite and Project