This hands-on Engineering position will provide Teleflex Medical OEM with technical support and operating knowledge for our medical device operation primarily support the OEM Strategic Initaiatives. This role will conduct critical engineering functions such as product line transfers, validations, troubleshooting, lean manufacturing, and identifying and implementing process improvements. The engineer will work with cross-functional teams to move pilot operations into production and lead subsequent transfer projects. The role will also be required to work withinternal and external vendors to design and specify tooling/fixturing.
Teleflex Medical OEM is the leading provider of comprehensive product development and production services to medical device manufacturers across the world. We set ourselves apart with deep expertise, decades of experience, and extensive, in-house capabilities, which include engineering, regulatory affairs, design for manufacturability, prototyping and validation, manufacturing, assembly and packaging. Our customers depend on Teleflex Medical OEM to deliver industry-changing innovations and next-generation solutions for precision extrusions, diagnostic and interventional catheters, sheath/dilator sets (introducers), medical balloons, specialty sutures and fibers, and bioresorbable sutures, yarns, and resins.
- Manage projects which support the OEM Strategic Initiatives.
- Function as Site Lead for all transfer activities.
- Provide technical guidance and mentorship to engineers and technicians in all OEM facilities in support of the OEM strategy.
- Liaison between Product Development and Manufacturing during product transfers to ensure successful transition.
- Support Process FMEAs and production transfer documentation
- Coordinate the design, procurement, build and debug of tooling, machinery and test equipment
- Work with Product Development to ensure Design for Manufacturability
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
- Develop, support and troubleshoot manufacturing processes related to catheter manufacturing in a clean room environment.
- Reduce cycle times and identify process improvements utilizing lean manufacturing principles and quality first mentality
- Conduct validations independently and assist technicians and junior engineers in executing validation protocols (IQ/OQ/PQ)
- Lead identification and execution of cost improvement program
- Work cross functionally with quality and operations as part of the "material review board" to ensure product quality
- Drive a safety driven culture
- Other duties as assigned
EDUCATION / EXPERIENCE REQUIREMENTS:
- Bachelor's degree in Engineering with a focus in Plastics, Chemical, Biomedical or Mechanical Engineering preferred
- 5years' experience in a medical device manufacturing or heavily regulated industry
SPECIALIZED SKILLS & OTHER REQUIREMENTS:
- Experience using statistical methods
- Experience with product transfers from development to production preferred
- Good oral and written communication skills
- Ability to prioritize and work independently
- Familiar with FDA documentation requirements, QSR and Good Manufacturing Practices
- Knowledge of process improvement methodology
- Experience writing and performing IQ/OQ/PQ
- Lean manufacturing experience
- Experience with Solidworks or other CAD software desirable
- Behaviors consistent to support a quality and safety driven culture
Teleflex is a global provider of specialty medical devices used for a range of procedures in critical care and surgery. We serve hospitals and clinicians in more than 130 countries with well known, trusted brands in vascular access, general and regional anesthesia, urology, respiratory care, cardiac care, and surgery. We also provide products and services for device manufacturers. Our products are designed to cost effectively provide clinical benefits and enable healthcare providers to improve outcomes and enhance patient and provider safety.
Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status.