Manufacturing Engineer

Role : Medical Device Manufacturing Engineer

Location: Warsaw IN
Duration: 6 months
Experience Required 4 - 6 years

(Prior Zimmer Biomet experience is preferred)
Technical/Functional Skills:
Experience supporting medical device manufacturing
Process Validations
Specific experience with process characterization equipment IQ/OQ process OQ and PQ
EOL validations including Cleaning Upgrade and Packaging
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 using 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
Microsoft Office Suite and Project

Roles & Responsibilities:

Develops and Executes Process Validation Strategies for EOL including Cleaning and Packaging: Creates plans protocols (IQ OQ PQ) and risk assessments to ensure effective processes for medical devices and equipment.
Ensures Regulatory Compliance: Adheres to FDA (21 CFR 820) ISO 13485 and other relevant regulations participating in audits and maintaining up-to-date knowledge.
Analyzes Data and Reports Findings: Compiles and analyzes validation data writes comprehensive reports and identifies trends for process improvement.
Collaborates Cross-Functionally: Works with Manufacturing Quality Assurance Engineering and other teams to implement cleaning strategies resolve issues and provide technical support.
Leads continuous improvement initiatives manages change controls troubleshoots cleaning problems and ensures proper documentation and training.
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)
Generic Managerial Skills Not Mandatory

Education Minimum B.S. degree from an ABET-accredited school (or global equivalent) in one of the following engineering disciplines 2-4 years of experience: Mechanical Engineering Mechanical Engineering Technology Biomedical Engineering Bioengineering Biomedical Engineering Technology Bioengineering Technology Aerospace Engineering or Aeronautical Engineering. Medical device particularly the Orthopedic industry experience preferred.