Product Development Engineer II

INTEGRA LIFESCIENCES CORP; Irvine (CA); On-site; USD 71,300 - 97,750; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) savings plan

Short- and long-term disability insurance

Job summary

INTEGRA LIFESCIENCES CORP is seeking a Product Development Engineer II to design and develop innovative ENT medical devices. This role supports cross-functional project teams, with responsibilities spanning product design, test method development, and compliance with regulatory standards.

The ideal candidate will possess a Bachelor’s Degree in Engineering, with 3–5 years of experience in medical device product development. The position includes a comprehensive benefits package with medical, dental, and 401(k) options.

Qualifications

• 3–5 years of related experience in medical device product development.
• Demonstrated ability to work effectively within cross‑functional technical teams.
• Working knowledge of design controls and risk management standards.

Responsibilities

• Design and develop ENT medical devices and related accessories.
• Collaborate with vendors to procure components and resolve design challenges.
• Develop and execute engineering tests and protocols.

Skills

CAD software proficiency

Project management

Strong communication skills

Problem-solving

Education

Bachelor’s Degree in Engineering

Advanced degree in Engineering or related field

Tools

SolidWorks

Microsoft Office applications

Statistical software (Minitab)

Process mapping (Visio)

Project management tools (Microsoft Project)

Job description

Position Summary

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.

Key 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.

Qualifications & 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).
• Advanced degree in Engineering, Physical Sciences, or a related field (preferred).
• 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.

Travel

Up to 25%.

Physical Requirements

Computer work, standing, sitting, walking, light lifting, talking, hearing, and hand‑eye coordination.

Work Environment

Onsite Lab and Office. Ability to thrive in a fast‑paced, stressful environment; strong analytical/problem‑solving skills; team collaboration; continuous learning mindset.

Salary & Benefits

Salary Pay Range: $71,300.00 – $97,750.00 USD. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Employees and/or eligible dependents are eligible to participate in company‑sponsored programs: medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, group legal insurance, and savings plan (401(k)).

Equal Opportunity Employer

Integra LifeSciences is an equal‑opportunity employer, 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. This site is governed solely by applicable U.S. laws and governmental regulations. All applicants are entitled to reasonable accommodations in accordance with the ADA.