Medical Device R&D Engineer

Cynet Systems • Irvine, CA

12h

About The Position

The R&D Engineer will play a key role in support of transcatheter aortic valve therapies. This role is responsible for leading and supporting key projects associated with commercialized products. Responsibilities include supporting product configuration changes, providing design control expertise for supply-chain driven manufacturing improvements, leading investigations into field performance issues, and supporting product labeling and training updates associated with global therapy expansion.

Requirements

• Bachelor's degree in an engineering or scientific field with four (4) years of quality engineering experience; OR Master's degree in an engineering or scientific field with three (3) years of quality engineering experience.
• Life sciences industry experience (e.g., medical device, pharma, or biotech).
• Experience with design controls, design verification and validation, or design test method development.
• Demonstrated experience reviewing and updating risk management-related documents.
• Experience utilizing statistical techniques to support design decisions and product acceptance testing.
• Strong verbal and written communication, listening, and diagnostic skills.
• Demonstrated collaboration and influencing skills to achieve results within cross-functional teams and with stakeholders across the organization.
• Ability to work well independently and as a member of a team.

Nice To Haves

• Master's degree in an engineering, scientific, or related discipline.
• Medical device industry experience.
• Experience in catheter-based therapies.
• Design control and design change experience for product improvements.
• Experience with sustaining activities for commercialized products.
• Strong experience in quality engineering, R&D, or manufacturing engineering.
• Design for Six Sigma or Lean Six Sigma Certification (Green Belt or XX Belt).
• Working knowledge and understanding of statistical techniques.
• Previous experience working with test lab equipment.
• Strong problem-solving, organizational, analytical, and critical thinking skills.
• Strong leadership skills and the ability to influence change.
• Knowledge of Design Control.
• Knowledge of applicable FDA regulations for the medical device industry.
• Ability to work effectively in a team environment, including inter-departmental teams, representing the organization on contracts or projects.

Responsibilities

• Provide engineering input to commercialized product projects including application of design control and risk management, developing solutions to a variety of problems of moderate scope and complexity.
• Serve as a subject matter expert on field performance of devices and the design features associated with key performance metrics.
• Apply mechanical and biomedical engineering principles to the design and development of components for delivery systems and accessories.
• Adapt to a broad scope of projects including material changes, manufacturing improvements, packaging and labeling changes, and usability changes.
• Develop test methods and procedures to evaluate device prototype performance.
• Assign support tasks, instruct technicians on conducting tests, train technicians, provide feedback, and coordinate technician work.
• Build partnerships with key cross-functional stakeholders.
• Maintain accurate documentation of concepts, designs, drawings, and procedures, generating written protocols, reports, and technical justifications or summaries.
• Perform other incidental duties assigned by leadership.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level