- Analyzes, designs, develops solutions to engineering challenges associated with Injection Molded plastic parts.
- Will have a responsibility to deliver engineering documents, conduct engineering reviews and may be involved with implementation oversight including mold validations and processing protocol development.
- Has experience working within the guidance of FDA/ISO -13485 Quality Systems requirements for the design and manufacture of medical devices in the Clean Room Manufacturing Environment.
- An expert position that requires a bachelor’s or master’s degree and several years of experience.
Accountabilities / Expectations
- Leads multiple capital projects in the area of plastic injection molding.
- 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 advanced level plastic injection molding 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 robust controlled plastics injection molding 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 molding process validations.
- Applies statistical analysis techniques to quantify current process capabilities.
- Trains and mentors molding 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.)
- Completes all work in a safe manner consistent with SteriPack USA’s Health’s safety & quality protocols.
- Is flexible on work hours and travel required to support international manufacturing sites and mold suppliers.
- 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 advanced degree in related field.
- Extensive experience in project management.
- Knowledge and experience in plastics injection molding 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.
- Experience in Scientific Injection Molding.
- High level of knowledge and aptitude of IQ, OQ, PQ validations/protocols for injection molding of medical components.
- Intimate knowledge of mold design and mold making.
- 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 the domestic U.S.
- Candidates will be expected to operate molding machines, and place molds into presses for startup and develop of molding processes.
- The candidate will be required to diagnose tooling issues on the bench and assemble/disassemble tooling 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
- Experience working with global teams.
- Manufacturing experience in a plant assignment.
- Lean Six Sigma green or black belt.
- RJG MM1 Certified. – some travel to Poland (manufacturing headquarters) to be exposed or to deploy technologies for plant production.