Product Development Engineer II

6 days ago

Clearwater, United States Endo-Therapeutics, Inc. Full time
Job Summary

We are seeking a highly skilled Product Development Engineer II to join our team at Endo-Therapeutics, Inc. This individual will be responsible for conceptualizing, prototyping, designing, and bringing new medical devices from inception through manufacturing and launch following a formal and regulated medical device design control process.

Key Responsibilities
  • Develop and implement product design and development strategies to meet user needs and market requirements.
  • Collaborate with cross-functional teams, including Marketing, Sales, Manufacturing, and Regulatory, to ensure design requirements are met.
  • Design and develop 3D models and 2D engineering specification drawings using CAD software.
  • Manage project plans, maintain project team meeting minutes, and provide senior management updates.
  • Provide support and collaborate with cross-functional groups and management throughout the product development cycle.
  • Exercise creativity in concept design through product development and manufacturing.
  • 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.
  • 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.
Requirements
  • Bachelor's degree in Mechanical, Manufacturing, Biomedical Engineering, or a relevant field of study.
  • At least two years of post-degree work experience preferably in a medical device environment.
  • Preferably 3 years of Medical Device Design experience in gastroenterology, urology, cardio-cath./stent, arthroscopy, or other relevant least/minimally invasive endoscopic medical device design.
  • 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.
  • Solid Works or other 3D modeling software.
  • Knowledge of plastic injection mold design and processes preferred.
  • Excellent technical writing, communication, and presentation skills.
Preferred Training
  • 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.
About Us

Endo-Therapeutics, Inc. is a medical device manufacturing company that takes great pride in our innovative products, exceptional quality, and unique company culture. We believe that a diverse and inclusive environment fosters creativity, collaboration, and excellence, enabling us to deliver cutting-edge solutions to meet the evolving needs of the healthcare industry.

We invite you to partner with Endo-Therapeutics, Inc. and experience firsthand our commitment to inclusiveness, innovation, and excellence. Together, we can drive advancements in medical device manufacturing, improve patient care, and make a positive impact on the healthcare industry.

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