Product Development Engineer III

Company Description

Endo-Therapeutics, Inc. is a renowned designer, developer, and manufacturer of high-quality single-use instruments for endoscopy. Our products, including biopsy forceps and polypectomy snares, are trusted by hospitals and surgery centers worldwide. Additionally, we excel in contract and private-label manufacturing services. Committed to innovation and quality, we play a vital role in advancing endoscopic technology and improving healthcare.

Role Description

• The Product Development Engineer III will act as the lead design engineer for electrosurgical snare, forceps, and cutting devices, overseeing the design and DFM of sub-assemblies and fully integrated products. Lead Risk Analysis (DFMEA) and ensure compliance with global standards, including ISO 13485 and IEC 60601-2-2 (particular requirements for high-frequency surgical equipment).Create new product designs and specifications integrating Marketing, Sales, Manufacturing, and Regulatory requirements to meet user needs (i.e., surgeon, clinical staff, patient)
• Create 3D models and 2D engineering specification drawings utilizing 2D-3D CAD (i.e. SolidWorks)
• Work with multiple cross-functional groups and design teams both inside and outside of the organization, to translate user needs and initial designs into technical specifications and "Design for Manufacturing" (DFM) requirements. Provide support and collaborate with cross-functional groups and management in and outside the core design team (i.e., Regulatory, Quality, Manufacturing, and Sales & Marketing) throughout the product development cycle.
• Oversee benchtop testing, tissue studies, and design verification to ensure device performance meets functional and safety benchmarks. Be able to incorporate design for manufacturing (DFM) into prototype and product design
• Exercise organization and presentation skills in effectively leading and managing multiple projects (e.g., new product development, sustaining engineering, continuous improvement, etc.)
• Understand and clearly articulate the clinical application of devices being developed
• Understand and utilize the company’s product development process and associated procedures
• Train and adhere to applicable procedures per the company’s Quality Management System
• Knowledge of plastic injection mold design and process

EDUCATION/ TRAINING:

• BS/MS in Mechanical, Biomedical, or Electrico-Mechanical Engineering.
• 7 years in medical device development, preferably with experience in minimally invasive surgery (MIS) or endoscopic instruments. Experience in applying design control and cGMP’s for Class I and II, IIa, IIb medical devices
• Experience applying analytical tools, including: GD&T, dFMEA, pFMEA, Risk Analysis, Statistical Analysis
• Project management skills
• Expert proficiency in 3D CAD (preferably SolidWorks).
• Knowledge of plastic injection mold design and processes preferred
• Excellent technical writing, communication, and presentation skills

Training including:

• Lean Six Sigma Green or Black Belt Training (including applied statistical methods)
• Gastroenterology or general endoscopic surgical technique seminars
• Engineering professional development courses on project management
• Training for Regulatory awareness of ISO 13485 and FDA GMP’s

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

·   Work performed in an office and factory settings.

·   Ability to manage multiple priorities.

·   Regularly required to sit, stand, and move around facilities.

COMMENTS:

Must maintain the reputation of ETI for outstanding customer relationship/support throughout the development process.