Integra LifeSciences

Senior Product Development Engineer I

$82KFull-time · Irvine-218-Facility, CA
✓ Verified live on the employer's own system · added 30 days ago
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Mid-level · 4+ yrs exp

Requirements

Education: Bachelor's degree

Experience: 4+ years

Skills & tools

Dimensional TolerancesManufacturing MethodsSketchingVerification And ValidationManagementCadCommunicationsProject Management

Benefits — mentioned in this posting

Bonus / commissionHealth, dental & vision401(k) / retirement
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Full job description

Key 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.

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., 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). 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). Travel: Up to 25%. Work Environment: Office, Remote, or Hybrid.

Salary Pay Range: $81,650.00 - $112,700.00 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 careers@integralife.com. 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 Whatever your specialty, you'll find an ideal setting for building a rewarding career. Along the way, you'll have the satisfaction of knowing your work matters, that it's making patients' lives better, making a positive and lasting difference.

You'll find that the pace is exhilarating - because the need is so urgent. You'll be challenged - and supported - by the most dynamic and inspiring people in your profession. And you'll grow a career that is more impactful and fulfilling then you thought possible.

More than 4,200 Integra employees already know we're a great place to build a career. Here's your chance to discover that for yourself.

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This posting was published by Integra LifeSciences on their own careers system and is shown here with a direct link to apply there. Employers: for corrections or removal, contact jobs@veritahire.com.