Director, R&D Engineering

1 Edwards Way, Irvine, CA 92614, USA

Full-TimeDepends on ExperienceSenior LevelBachelors

Job Description

This is an exciting opportunity for an experienced medical device Director, R&D Engineering, with strong technical experience and exceptional leadership skills to contribute to the leading-edge transcatheter heart valve program. Oversee execution of valve frame and materials testing and related activities to comply with FDA and ISO requirements. Develop overall test strategies for frames and materials. Oversee preparation of test data for Regulatory submissions. Develop innovative test strategies to shorten time to regulatory approvals. Support R&D efforts with test plans to verify performance of next generation technologies. Support Manufacturing efforts to incorporate technical advancements into the manufacturing process. Support Manufacturing efforts to implement quality improvement project. Ensure testing reports are accurate, analyzed appropriately and completed in a timely manner to meet project needs.

Where is this job?

This job is located at 1 Edwards Way, Irvine, CA 92614, USA

Job Qualifications

12+ years of experience in an engineering capacity within the medical device industry
4+ years managing and developing talent - ability to lead and develop talent is essential
Strong background in heart valves or stents is preferred. Background with class III medical devices and knowledge of PMAs
Must have participated in GMP and ISO compliance audits

Required Skills

Customer Relationship Management
Time Management Skills
Compliance Reporting
Regulatory documentation
Fatigue testing

Soft Skills

Process Improvement
Prioritizing skills
Detail Oriented and Organized
Verbal and Written Communication
Multi tasker
Flexibility and adaptability
Driven for excellence

Compensation

According to JobzMall, the average salary range for a Director, R&D Engineering in 1 Edwards Way, Irvine, CA 92614, USA is $139,000-$167,000. Salaries vary based on experience, education, and other factors.

Additional Information

Edwards Lifesciences is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Required LanguagesEnglish

Job PostedAugust 2nd, 2021

Apply BeforeMay 22nd, 2025

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