ResponsibilitiesWe are seeking a talented and motivated
R&D Engineer II to join our dynamic team of innovators in Irvine, California. As an R&D Engineer, you will play a pivotal role in the development and enhancement of our combination medical devices. Working closely with a multidisciplinary team, you will contribute to the design, prototyping, testing, and validation of innovative medical devices that have the potential to transform patient care.
Key Accountabilities- Execute product and process development activities including design, testing, and analysis.
- Support development and execution of design verification and validation protocols.
- Prepare and maintain design documentation, including drawings, specifications, and reports.
- Perform failure analysis and recommend design or process improvements.
- Collaborate with Manufacturing, Quality, and Analytical teams to ensure robust design transfer.
- Support regulatory submissions by providing engineering documentation and test data.
- Participate in risk assessments and implement design mitigation strategies.
- Maintain compliance with ISO 13485, FDA 21 CFR Part 820, and company procedures.
- Contribute to continuous improvement of design and development processes.
QualificationsRequired Qualifications- Bachelor's degree in Mechanical, Biomedical, or Chemical Engineering.
- 3+ years of experience in medical device product development or combination of education and experience.
- Strong knowledge of design controls and risk management principles.
- Proficiency with SolidWorks or equivalent CAD software.
Preferred Qualifications- Experience with combination product development.
- Familiarity with balloon catheter manufacturing or coating processes.
Key Competencies- Technical proficiency and attention to detail.
- Strong analytical and communication skills.
- Ability to manage multiple priorities in a collaborative environment.
- Problem-solving and continuous improvement mindset.
Working Conditions- Laboratory and office environment.
- May require standing or bending for extended periods.
- Light lifting (up to 25 lbs.)
Preferred QualificationsPay / CompensationThe expected pre-tax pay rate for this position is $78,650 - $105,600 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
