Product Development Engineer II

Integra LifeSciences•Irvine, CA

3d•$71,300 - $97,750•Onsite

About The Position

The Product Development Engineer II will play a key role in the design and development of innovative ENT (Ear, Nose, and Throat) medical devices at Acclarent. This position supports cross-functional project teams throughout the product lifecycle, with a focus on product design, design for manufacturability (DFM), test method development, and product verification and validation (V&V) activities. The role requires a hands-on engineer who can translate concepts into reliable, high-quality medical devices while ensuring compliance with regulatory standards and business objectives.

Requirements

Bachelor’s Degree in Engineering (or equivalent) required.
3–5 years of related experience in medical device product development.
Proficiency with CAD software (e.g., SolidWorks).
Demonstrated ability to work effectively within cross-functional technical teams.
Strong verbal and written communication skills, with experience in project management, problem-solving, and presentations.
Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).

Nice To Haves

Advanced degree in Engineering, Physical Sciences, or a related field.
Working knowledge of design controls, risk management (ISO 14971), production/process controls, and relevant standards (e.g., ISO 13485, FDA Quality System Regulation).
Experience with statistical software (e.g., Minitab), process mapping (Visio), and project management tools (Microsoft Project).
Strong business acumen and the ability to collaborate across all levels of the organization.

Responsibilities

Design and develop ENT medical devices and related accessories (e.g., cables, sheaths, suctions).
Collaborate with external vendors to develop and procure components; 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.
Create preliminary sketches and detailed design concepts; perform measurements, analyses, and create engineering prototypes.
Develop and execute engineering tests, including benchtop, verification & validation (V&V), and pre-clinical studies; author comprehensive protocols and reports.
Communicate project status, risks, and opportunities effectively to project teams and 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.