As a leading manufacturer of vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair, and sutures, we are looking for an experienced scientist/engineer to join our team in Wall, NJ.
You will work closely with teams that include colleagues in engineering, manufacturing, and sales and marketing to provide hands-on product and process development in support of catheter-related projects.
Responsibilities will include:
* Performing hands-on experimental design and execution, generating and evaluating prototypes, assessing product fitness for use, and ensuring completion of process scale-up and validation
* Effectively transitioning new technologies
* Designing, executing, and analyzing experiments and data using appropriate statistical techniques
* Partnering with manufacturing to support existing products on issues such as troubleshooting, corrective and preventative actions (CAPA), process improvements, cost reduction efforts, etc.
* Driving appropriate material selection, evaluation, and validation as they relate to new-product development requirements
* Creating procedures and providing training and coaching for technical and manufacturing associates
* Leading projects and project teams as needed to support new product and technology introductions
Required Job Qualifications
* Bachelors' degree in engineering or science
* At least 10 years' experience in thermoplastic extrusion or catheter design. An advanced degree may be considered in lieu of the full 10 years' experience.
* Hands-on experience in the thermoplastic molding and extrusion process, or a strong technical background in a relevant field
* Proven ability to effectively interact with and influence cross-functional associates in manufacturing, quality assurance, regulatory, product specialist, technical, and plant leadership roles
* Advanced knowledge and applied use of statistically based analysis
* Demonstrated ability to troubleshoot and resolve complex technical and quality issues
* A work style of hands-on involvement with all phases of projects
* Willingness to travel periodically
Desirable Job Qualifications
* Advanced degree in engineering or science
* Experience in:
>The medical-device or pharmaceutical industries
>New-product design and materials
>Medical-device and component quality systems
>Product development (internal and contract)
Travel: Yes, 5% of the time
Shift: Day (1st shift)
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