SysMind Tech
SysMind Tech is hiring: Manufacturing Validation Engineer in Warsaw
SysMind Tech, Warsaw, IN, United States
Job Title - Manufacturing Validation Engineer
Location - Warsaw, IN
Client- (FULLTIME)
Job Description:
Experience Required 2 - 4 years
Roles & Responsibilities
Location - Warsaw, IN
Client- (FULLTIME)
Job Description:
- Experience in supporting medical device manufacturing.
- Specific experience with process characterization, equipment IQ/OQ, process OQ, and PQ
- Validation Experience, especially cleaning
- Processes experience, molding, cleaning, 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 ISO13485-2003
- Ability to lead and prioritize multiple medium-complexity project assignments and complete work in a timely manner.
- Good problem-solving skills through tperson use of quality and statistical tools, Six Sigma
- 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 tperson Change Management System, Nonconformance Reports, Engineering Specifications, Corrective and Preventive Action (CAPA), and Work Instructions and proficient with Statistical Process Control concepts, process development, CNC programming terminology, and tooling design concepts.
- Microsoft Office Suite and Project
Experience Required 2 - 4 years
Roles & Responsibilities
- 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, molding, cleaning, personat treating, bonding, molding, etc.
- Conducting feasibility studies 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 scpersondules for work activities
- Communicate (written and verbal) direction and project plans with appropriate personnel from otperson departments.
- Evaluating multiple options to select tperson most appropriate processes and machining methods.
- Execute equipment qualification and process validations.