Product Development Engineer II
4 weeks ago
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 design control procedures to ensure compliance with FDA regulations and industry standards.
- Collaborate with cross-functional teams to design and develop new medical devices, including marketing, sales, manufacturing, and regulatory requirements.
- 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 from initial concept through product launch.
- Provide support and collaborate with cross-functional groups and management in and outside the core design team throughout the product development cycle.
Requirements:
- Bachelor's degree in Mechanical, Manufacturing, Biomedical Engineering, or a relevant field of study with at least two years of post-degree work 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 Endo-Therapeutics, Inc.
Endo-Therapeutics, Inc. is a medical device manufacturing company that takes great pride in our innovative products, exceptional quality, and, most importantly, our unique company culture. At Endo-Therapeutics, we firmly 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.
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