About Teleflex Incorporated
Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.
OEM – Teleflex Medical OEM is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.
This position’s responsibility is for new product and business development; the Balloons Product Development Engineer will develop new products specifically for balloon forming and balloon catheter applications while interfacing with customers, vendors, and internal departments to achieve the desired product specifications. The goal is to develop products, define specifications, to establish reasonable time lines while developing high quality products that meet the end users’ expectations. Success in this postion relies heavily on meeting dates and maintaining accountability while using experience and judgment to develop products and meet goals with minimal supervision.
- Plan and manage medical device product development efforts including customer interaction, specification and design input documentation, product design requirements, manufacturing process development, risk analysis, design control and process and design documentation.
- Create appropriate documentation required to validate the manufacturing process of a new product under TFX Design Controls Operational Procedures and ISO 13485 Quality System Requirements. Documents required but not limited to: Process Validation Protocols/Reports, Risk Assessment Protocols/Reports including PFMEA’s. This will also require the ability to create IQ, OQ and PQ’s as the fundamental core of each process validation. Process validations will include but not limited to: Thermal Bonding and Catheter Reflow, Balloon Bonding (Adhesive, Thermal, Laser), Injection Molding, Catheter Joining, Thermoforming and Packaging Pouch Sealing.
- Participate in overall product development program management system including regular meetings and discussions around project priorities and project status updates.
- Develop prototypes of medical balloons and balloon catheters
- Dig deep into developing balloons from the ground-up and develop an advanced understanding of the processes and parameters of balloon blowing.
- Work closely with the Sr. Engineering staff, Technicians, and Operators to develop balloon forming parameters using both compliant and non-compliant balloon materials.
- Operate and set-up Interface BFM style machines to run both development and production balloon orders.
- Train and supervise technicians and assemblers in the manufacture of engineering project devices.
- Identify new manufacturing or product technologies for review and possible development activities within the product development group.
- Identify and manage vendor relationships to support introduction of new product designs to the market.
- Travel to customers, vendors and alternate manufacturing locations as needed.
- Apply appropriate quality procedures and product documentation to production builds and monitor each for quality conformance.
- Develop a complete understanding of TFX documentation system as it applies to development and manufacturing.
- Understand and utilize yield analysis data as a continuous improvement tool.
- Is aware of general equipment hazards and follows and utilizes all applicable safety standards.
- Perform other duties as assigned.
Education / Experience Requirements
- Bachelor’s degree in Engineering required: Mechanical, Chemical, Biomedical or related technical field preferred
- 2 years’ experience in medical device manufacturing required.
- Previous experience in catheter design and balloons required
- Prior experience with Medical Device Regulatory pathways is highly preferred.
Specialized Skills / Other Requirements
- Proven track record for project management, problem solving, sound decision making and project competitions; the ability to manage development programs across multiple locations and project teams.
- Working knowledge of manufacturing processes related to catheter production, molding and extrusion.
- Working knowledge of QSR requirements for medical devices including design control for contract manufactured product and new product development efforts.
- This position requires exerting 10 pounds of force frequently and 50 pounds of force occasionally.
- The noise level in the work environment is usually moderate.
- To perform this position function successfully, an individual must be able to perform each essential duty satisfactorily.
- Advanced computer skills are required; Experience with Solidworks and Microsoft Office specifically with Excel and Word software programs required. Experience with MiniTab software preferred. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Prior training in Right to Know, GMP, and Clean Room Procedures is required.
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. If you require accommodation to apply for a position, please contact us at: 262-439-1894.