Report this job

---

What is the problem? *

Incorrect company
Incorrect location
Job is expired
Job may be a scam
Other

Role :: Manufacturing Engineer
Location :: Warsaw, IN 46580
Duration :: Contract (long term)

Role Description::

Relevant Experience (in Yrs.) :: 2 - 4 years

Technical/Functional Skills

• Medical devices technical transfer experience
• 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 problem-solving for both technical and process issues
• Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485-2003Ability to lead and prioritize multiple medium-complexity project assignments and complete work in a timely manner
• Good problem-solving 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), Critical-to Quality (CTQ) Analysis
• Knowledge of Quality System requirements, ISO and FDA requirements
• Ability to effectively work within a cross-functional 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

Roles & Responsibilities

• Medical devices technical transfer
• Supporting medical device manufacturing
• Process characterization, equipment IQ/OQ, process OQ, and PQ
• Test method Validation, Gage R&R
• Creating, maintaining, and improving controlled technical documents such as prints, procedures, bills of materials, and routers.
• Supporting a wide variety of processing applications such as machining, finishing, forging, casting, cleaning, heat treating, bonding, molding, etc.
• Conducting feasibility study to estimate a product cost and analyze capital equipment, capacity, and capability requirements
• Establishing and improving process methods that meet performance and quality requirements
• Developing and executing project plans and schedules for work activities
• Communicate (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
• Execute equipment qualification or process validation project(s)