MDR Packaging Engineer
Share
Job Location:
Lafayette, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Job Description & Skill Requirement:
Must Have:
Medical device design development & manufacturing experience of products with electrical functionality an advantage
Examples of critical thinking and proven project execution
Leading a cross functional teams and leveraging solid PM skills e.g. project planning communication risk management etc. Work collaboratively and with respect & humility with a cross functional team to drive project execution for medical devices prioritizing safety quality service on-time execution.
Lead team to define goals provide solutions and align on path forward drive/track/communicate progress adapt as needed with team.
Read and understand quality management system documents that provide details of business processes to be used and comply with those procedures.
Use scientific problem solving methodologies e.g. DMAIC process map.
whys Is/Is not etc. Drive solid decision making.
Attention to detail accuracy to ensure own work meets required standard (compliant to quality management system grounded in scientific facts and/or data within safety/scope/schedule/cost guidance).
Understand priority drive critical path and monitor secondary critical paths for progress communicate early any challenges
Experience with medical devices sterilization methods (i.e. ethylene oxide radiation etc.) Experience implementing appropriate risk mitigation actions with knowledge of packaging or process and process Risk Management as per FDA & ISO standards.
Six Sigma/ Design for Six Sigma experience and/or knowledge of Process Excellence tools. Working knowledge of SolidWorks or other packaging CAD programs (i.e. TOPS SolidWorks CREO etc.).
Experience with Minitab or other statistical software.
Nice to Have:
Change control of Medical Devices
Equipment Commissioning / Qualification
Process Validation
Computer System Validation (CSV)
Manufacturing Packaging and Laboratory Equipment
Technical experience (Trouble shooting) or any similar experience or background
Quality / Process Control / Assurance of Medical Devices
Must Have:
Medical device design development & manufacturing experience of products with electrical functionality an advantage
Examples of critical thinking and proven project execution
Leading a cross functional teams and leveraging solid PM skills e.g. project planning communication risk management etc. Work collaboratively and with respect & humility with a cross functional team to drive project execution for medical devices prioritizing safety quality service on-time execution.
Lead team to define goals provide solutions and align on path forward drive/track/communicate progress adapt as needed with team.
Read and understand quality management system documents that provide details of business processes to be used and comply with those procedures.
Use scientific problem solving methodologies e.g. DMAIC process map.
whys Is/Is not etc. Drive solid decision making.
Attention to detail accuracy to ensure own work meets required standard (compliant to quality management system grounded in scientific facts and/or data within safety/scope/schedule/cost guidance).
Understand priority drive critical path and monitor secondary critical paths for progress communicate early any challenges
Experience with medical devices sterilization methods (i.e. ethylene oxide radiation etc.) Experience implementing appropriate risk mitigation actions with knowledge of packaging or process and process Risk Management as per FDA & ISO standards.
Six Sigma/ Design for Six Sigma experience and/or knowledge of Process Excellence tools. Working knowledge of SolidWorks or other packaging CAD programs (i.e. TOPS SolidWorks CREO etc.).
Experience with Minitab or other statistical software.
Nice to Have:
Change control of Medical Devices
Equipment Commissioning / Qualification
Process Validation
Computer System Validation (CSV)
Manufacturing Packaging and Laboratory Equipment
Technical experience (Trouble shooting) or any similar experience or background
Quality / Process Control / Assurance of Medical Devices
Pi-square technologies is a Michigan (USA) Headquartered Automotive Embedded Engineering Services company Synergy Partner for major OEMs and Tier 1s and their implementation partners in Automotive Embedded Product Development Projects Requirements Analysis Software Design Software Implementation Efficient Build Release Process and turnkey software V & V Services. We have more than 20 years of industry expertise with specialization in the latest cutting-edge automotive technologies such as Infotainment connected vehicles Cyber security OTA and Advanced Safety/ Body electronics.
Key Skills
- Continuous Integration
- Food Industry
- Minitab
- Packaging
- CAD
- Mechanical Knowledge
- Plastics Blow Molding
- SolidWorks
- Mechanical Engineering
- Plastics Injection Molding
- Microsoft Project
- Manufacturing
