- Analyses, designs, set-up, and develops manufacturing solutions to engineering challenges associated with Additive Manufacturing (3D Printing) polymer parts
- Provide customer support, including technical support and direct support to accelerate the closure of sales proposals
- Build strong technical relationships with key customer stakeholders to promote the use of Additive Manufacturing (3D Printing) processes
- Promote SteriPack capabilities in Additive Manufacturing (3D Printing) by creating White Papers and Technical articles
- Will have a responsibility to deliver engineering documents, conduct engineering reviews and may be involved with implementation oversight including equipment, material validations and processing protocol development
- Builds the process capability for additive to meet the quality standards FDA/ISO-13485 Quality Systems required for the design and manufacture of medical devices
- Provide training to technical personnel, sales personnel and customers in the use of Additive Manufacturing (3D Printing) technology
- Support the develop, launch and roll-out of SteriPack Additive Manufacturing globally
- When necessary, be hands-on with equipment to develop processes and meet project goals
Accountabilities / Expectations
- Leads multiple capital projects in the area of Additive Manufacturing (3D Printing)
- Provides leadership and collaboration within a cross-functional team during the execution of projects.
- Manages the day-to-day operational and tactical aspects of multiple projects.
- Manages scope and mitigates risk across projects.
- Effectively achieves results that meet business and individual objectives.
- Provides expertise in Additive Manufacturing (3D printing) process troubleshooting support and data analysis, identifies areas for improvement and participates in or leads continuous improvement activities to reduce variability and improve production efficiencies.
- Provides technical guidance on the development and commissioning of Additive Manufacturing (3D printing) systems for manufacturing applications.
- Establishes material and machinery standards for processes and products.
- Leads process improvement using modern manufacturing tools and methods.
- Leads and supports Additive Manufacturing (3D printing) process validations.
- Applies statistical analysis techniques to quantify current process capabilities.
- Trains and mentors Additive Manufacturing (3D printing) process technicians, plant engineers and key operations personnel to develop and enhance process knowledge and skills.
- Manages multiple external partners (i.e. Engineering Service Providers, Equipment vendors, etc.)
- When necessary, be hands-on with Additive Manufacturing (3D Printing) processes.
- Completes all work in a safe manner consistent with SteriPack’s Health’s safety & quality protocols.
- Is flexible on work hours and travel required to support international manufacturing, suppliers and customers.
- Manages self and team in accordance with SteriPack’s Behaviors and Culture of Accountability principals.
- Candidate must possess a minimum of a bachelor’s or advanced degree in engineering or a related major scientific discipline from an accredited college or university, or equivalent experience and continuing self-development, and/or progress toward an advanced degree in the related field.
- Knowledge and experience in Additive Manufacturing (3D printing) processes, tools and materials
- Knowledge and experience in statistical analysis and statistical process control
- Experience leading continuous improvement efforts to improve efficiencies and costs
- A demonstrated ability to work independently or as part of a team to complete projects within required timeframes
- Job is expected to require some travel to/from customer locations for engineering review and kick-off meetings during project design & launch phases or during a manufacturing or supply crisis. Any required travel would be predominately in Europe
- Candidates will be expected to operate Additive Manufacturing machines and follow the process steps for start-up and develop of Additive Manufacturing processes
- The candidate will be required to diagnose Additive Manufacturing (3D printing) issues on the production line and production line operations as required
- The candidate will be required to conduct on machine DOE’s and on machine trials and experiments in a hands-on manner
- Previous experience in FDA regulated industries
- Knowledge and aptitude of IQ, OQ, PQ validations/protocols for medical production lines.
- Experience working with global teams.
- Manufacturing experience in a plant assignment.
- Lean Six Sigma green or black belt.