Product Development Engineer II

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