Apolis ยท 2 months ago
MDR- Packaging Engineer
Lafayette, CO
Full-time
Onsite
Mid, Senior Level
$50/hr - $50/hr
2+ years expApolis is a company seeking a MDR- Packaging Engineer to manage OEM Packaging opportunities for distributed products and develop sterile and non-sterile packaging for spinal implants and instruments. The role involves leading cross-functional teams, ensuring compliance with quality management systems, and utilizing scientific problem-solving methodologies to drive project execution.
ConsultingEnterprise ApplicationsEnterprise Resource Planning (ERP)Information TechnologyIT InfrastructureIT ManagementMobileSoftwareWeb Hosting
Responsibilities
The role will include managing OEM Packaging opportunities for distributed products and / or development of sterile and non-sterile case and tray packaging for spinal implants and instruments
This includes the Design History File documentation to support the development activities
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
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
Qualification
Required
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
CREO drawing software
Sterile Packaging / Medical Device Packaging Development
Project Management skills, including MS Project timeline and design history file management
Preferred
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
Company
Apolis
Apolis is a IT consultancy that offers provides ERP solutions, hosting, assessment, web and mobile, IT staffing and IT workforce solutions.
501-1000 employees
H1B Sponsorship
Apolis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (15)
2022 (15)
2021 (12)
2020 (122)
Funding
Current Stage
Late StageLeadership Team
Amar Shokeen
President/ CEO
Rita Shokeen
COO
Company data provided by crunchbase