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Product Development Engineer II

2 months ago

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

PURPOSE OF THE POSITION:

To conceptualize, prototype, design, and bring new medical devices from inception through manufacturing and launch following a formal and regulated medical device design control process

RESPONSIBILITIES:

  • Specific product/process design and project management duties include but are not limited to the development, formulation, documentation, and project management activities associated with: concept and prototype development, formulation of design requirements, Design and Process Failure Modes and Effects Analysis, Risk Analysis, design/process verification and validation test methods (protocols, statistical analysis and reports), manufacturing transfer, design history file, design reviews, post launch continuous improvement and design change.
  • 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)
  • Manage project plan (e.g. Gantt chart), maintain project team meeting minutes and/or 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 (i.e. Regulatory, Quality, Manufacturing, and Sales & Marketing) 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 (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

 

GENERAL OBJECTIVES:

  • Complete projects on schedule and within budget
  • Gain and utilize product and clinical application knowledge of devices used in the endoscopic market
  • Understand and apply design control procedures used by ETI
  • Design devices that will readily transition to ETI Manufacturing

 

QUALITY OBJECTIVES:

  • Conduct product development and design control in compliance with all applicable standards and guidelines (i.e. FDA 21 CFR, ISO 9001, ISO 13485, ISO 60601, cGMP, etc.)
  • Create test protocols that will accurately verify and validate design inputs
  • Stay current and trained on applicable procedures, standards and guidelines

 

EXPERIENCE REQUIRED:

  • Bachelor's degree in either Mechanical, Manufacturing, Biomedical Engineering or a relevant and applicable 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 ggastroenterology, 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

 

TRAINING PREFERRED:

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

 

COMMENTS:

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

 

Company DescriptionEndo-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.

Our commitment to creating a great culture of inclusiveness sets us apart. We believe that diverse perspectives and backgrounds fuel innovation and drive our success. We celebrate individuality and actively promote an environment where every employee feels valued, respected, and empowered to contribute their unique talents and ideas.

In addition to our commitment to inclusivity, we pride ourselves on our relentless pursuit of excellence in everything we do. We have assembled a highly skilled and passionate team of professionals who are driven by a shared dedication to improving patient outcomes. Through continuous innovation and rigorous quality standards, we ensure that our medical devices meet the highest industry standards and deliver exceptional performance in the hands of healthcare professionals.

As an organization, we embrace a collaborative approach that encourages open communication and teamwork. We foster an environment where ideas are shared, challenges are overcome together, and everyone is empowered to contribute their expertise. This collective effort allows us to develop comprehensive solutions that address the complex and evolving needs of healthcare providers and patients alike.

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.Company DescriptionEndo-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.\r
\r
Our commitment to creating a great culture of inclusiveness sets us apart. We believe that diverse perspectives and backgrounds fuel innovation and drive our success. We celebrate individuality and actively promote an environment where every employee feels valued, respected, and empowered to contribute their unique talents and ideas.\r
\r
In addition to our commitment to inclusivity, we pride ourselves on our relentless pursuit of excellence in everything we do. We have assembled a highly skilled and passionate team of professionals who are driven by a shared dedication to improving patient outcomes. Through continuous innovation and rigorous quality standards, we ensure that our medical devices meet the highest industry standards and deliver exceptional performance in the hands of healthcare professionals.\r
\r
As an organization, we embrace a collaborative approach that encourages open communication and teamwork. We foster an environment where ideas are shared, challenges are overcome together, and everyone is empowered to contribute their expertise. This collective effort allows us to develop comprehensive solutions that address the complex and evolving needs of healthcare providers and patients alike.\r
\r
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.