Senior Product Development Engineer I

Integra LifeSciences•Irvine, CA

1d•$81,650 - $112,700•Hybrid

About The Position

The Senior Product Development Engineer I will play a critical leadership role in the full lifecycle development of innovative ENT (Ear, Nose, and Throat) medical devices at Acclarent — from concept through commercial release. This position leads technical aspects of projects while supporting cross-functional teams in design, design for manufacturability (DFM), test method development, verification, validation, and usability testing. The ideal candidate is a hands-on technical leader with strong business acumen who can drive complex projects and mentor team members in a regulated medical device environment.

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).

Nice To Haves

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).

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.