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Senior Product Development Engineer

Job in Irvine, Orange County, California, 92713, USA
Listing for: INTEGRA LIFESCIENCES CORP
Full Time position
Listed on 2026-07-03
Job specializations:
  • Engineering
    Quality Engineering, Product Engineer, Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 81650 - 112700 USD Yearly USD 81650.00 112700.00 YEAR
Job Description & How to Apply Below
Position: Senior Product Development Engineer I

Senior Product Development Engineer I – Acclarent

Lead the full lifecycle development of innovative ENT medical devices, serving as a technical leader in design, manufacturability, testing and cross‑functional collaboration.

Key Responsibilities
  • Design and develop ENT medical devices and related accessories (e.g., cables, sheaths, suctions, balloons).
  • Interface with external vendors to procure components and 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, 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 to management.
  • Ensure compliance with all applicable regulations and company policies related to Health, Safety, and Environmental practices.
  • Perform other duties as assigned.
Qualifications & 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., Solid Works).
  • Demonstrated ability to lead technical teams.
  • Strong verbal and written communication skills, with experience in project management methodology, problem‑solving, and presentations.
  • Strong business acumen and collaboration across 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 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).
Travel & Work Environment
  • Travel:
    Up to 25%.
  • Work Environment:
    Office, Remote, or Hybrid.
  • Salary Pay Range: $81,650.00 – $ USD (variable compensation may apply).
Benefits
  • Medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, group legal insurance, and a 401(k) savings plan.
EEO Statement

Integra Life Sciences is an equal opportunity employer, committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. We provide reasonable accommodations for qualified applicants with disabilities under the Americans with Disabilities Act.

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Position Requirements
10+ Years work experience
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