Senior Product Development Engineer I

Integra LifeSciences is a company focused on innovating new treatment pathways to advance patient outcomes in healthcare. The Senior Product Development Engineer I will lead the full lifecycle development of ENT medical devices, overseeing technical aspects while collaborating with cross-functional teams to ensure successful project execution.

Responsibilities:

• Design and develop ENT medical devices and related accessories (e.g., cables, sheaths, suctions, balloons)
• Interface with external vendors to develop and procure components; proactively resolve design challenges related to materials, specifications, tolerances, service requirements, manufacturing processes, and cost
• Develop tools, jigs, and fixtures to support prototyping, manufacturing, and testing activities
• Create preliminary sketches and detailed design concepts; perform measurements, analyses, and produce engineering prototypes
• Develop and execute engineering tests (benchtop, verification & validation (V&V), pre-clinical, and usability); author detailed protocols and comprehensive reports
• Gather Voice of the Customer (VOC) input from physicians and end-users to inform product requirements and improvements
• Lead technical reviews, including design reviews and technical assessments
• Recommend, design, and/or purchase equipment needed for development and testing
• Communicate project status, risks, business-related issues, and opportunities effectively to the next level of management
• Ensure compliance with all applicable federal, state, and local regulations, as well as company policies related to Health, Safety, and Environmental practices
• Perform other duties as assigned

Requirements:

• Bachelor's degree in engineering (or equivalent) required
• At least 4 years of related experience in medical device product development
• Proficiency with CAD software (e.g., SolidWorks)
• Demonstrated ability to lead technical teams
• Strong verbal and written communication skills, with solid experience in project management methodology, problem-solving, and presentations
• Strong business acumen and the ability to collaborate effectively with all levels of management in a cross-functional team environment
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint)
• Mechanical Engineering degree preferred
• Working knowledge of design controls, risk management (ISO 14971), production and process controls, and relevant regulatory standards (ISO 13485, FDA Quality System Regulation)
• Experience with statistical analysis software (e.g., Minitab), process mapping (Visio), and project management tools (Microsoft Project)