Product Development Engineer II

Posted 3 Days Ago
Be an Early Applicant
Irvine, CA, USA
In-Office
71K-98K Annually
Mid level
Healthtech • Manufacturing
The Role
Design and develop ENT medical devices and accessories, create prototypes, tools, and test methods, execute V&V and pre-clinical studies, collaborate with vendors and cross-functional teams, ensure regulatory and quality compliance, and communicate project status and risks.
Summary Generated by Built In

Changing lives. Building Careers.
 

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

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 Integra LifeSciences. 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

Qualifications:

  • 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.
  • 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 Pay Range:

    $71,300.00 - $97,750.00 USD Salary

    Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

    Additional Description for Pay Transparency:

     

    Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

     

    Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences

    Integra LifeSciences is an equal opportunity employer, and is 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.
    This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
    EEO Is the Law | EOE including Disability/Protected Veterans
    Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at [email protected].

    Unsolicited Agency Submission

    Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

    Integra - Employer Branding from Integra LifeSciences on Vimeo

    Skills Required

    • Bachelor's Degree in Engineering (or equivalent)
    • 3-5 years of related experience in medical device product development
    • Proficiency with CAD software (SolidWorks)
    • Demonstrated ability to work effectively within cross-functional technical teams
    • Strong verbal and written communication skills; experience in project management, problem-solving, and presentations
    • Proficiency in Microsoft Office applications (Word, Excel, PowerPoint)
    • Advanced degree in Engineering, Physical Sciences, or related field
    • Working knowledge of design controls, risk management (ISO 14971), production/process controls, ISO 13485, and FDA Quality System Regulation
    • Experience with statistical software (Minitab), process mapping (Visio), and project management tools (Microsoft Project)
    • Ability to travel up to 25%
    • Ability to thrive in a fast-paced environment with strong analytical/problem-solving skills and team collaboration
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    The Company
    HQ: Princeton, New Jersey
    3,489 Employees

    What We Do

    Integra LifeSciences, a world leader in medical technology with headquarters in Princeton, New Jersey, was founded in 1989 with the acquisition of an engineered collagen technology platform used to repair and regenerate tissue. Since then, Integra has expanded its base regenerative technology product portfolio to include surgical instruments, neurosurgical products and advanced wound care products, through global acquisitions and development of new and innovative products and technologies to address unmet patient needs and improve outcomes. Integra is a global leader in neurosurgery and offers a broad portfolio of products and solutions for dural access and repair, cerebral spinal fluid management and neuro-critical care. Our regenerative tissue technologies include products that address soft tissue, nerve and tendon repairs and for the treatment of acute and chronic wounds, burns, as well as for plastic and reconstructive surgery. The company has offices, manufacturing and research facilities in Asia, Australia, Europe, Middle East, and the Americas. Integra products are ubiquitous in many hospital intensive care units and operating rooms around the world. Some of our high quality leading brands include AmnioExcel®, Bactiseal®, CerebroFlo®, CereLink® Certas® Plus, Codman®, CUSA®, Cytal®, DuraGen®, DuraSeal®, Gentrix®, ICP Express®, Integra®, MatriStem® UBM, MAYFIELD®, MediHoney®, MicroFrance®, MicroMatrix®, NeuraGen®, NeuraGen® 3D, PriMatrix®, SurgiMend®, TCC-EZ® and VersaTru® and are available through a combination of directly employed sales representatives, distributors and wholesalers

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