Engineer I/II or Senior

Job Description :

Foldax is developing a complete line of surgical and catheter-delivered (TAVR/TMVR) synthetic heart valve products. We are looking for the ideal candidate to join our team. This position will be on a fast-paced, early product development team and the individual who fills it will play a key role in the design, development and testing of valve designs from concept to early clinical feasibility.

Qualifications :

• You will collaborate with cross-functional teams to bring projects from concept to completion and ensure all products meet quality standards. To be successful in this position, you must possess a bachelor’s degree in engineering, preferably mechanical or biomedical engineering, and have 3 years of experience in the medical device industry
• You should also have a working knowledge of design control and risk management.
• The ideal candidate will have an entrepreneurial spirit and be comfortable working in a fast-paced environment. If you’re passionate about developing cutting-edge technologies that make a positive impact on people’s lives, then this job is for you!

Responsibilities

• In this role, you will be responsible for designing, developing and testing new transcatheter heart valve device
• Implement complex design concepts and ideas into working drawings, solid models, and prototypes
• Prototype design and performing feasibility assessments at a rapid pace
• Run empirical and experimental analysis utilizing various analytical design tools to support design improvements.
• Ensure all products meet quality standards
• Develop and execute test methods, procedures, work instructions and reports with minimal supervision
• Write, execute, and summarize qualification and validation reports
• Use technical problem-solving techniques for solving basic equipment issues
• Supervise technicians/interns and coordinate project activities
• Largely self-directed and capable of meeting project goals with minimal supervision

Additional Information:

• The primary work location for this position is Irvine, CA.
• This is a 100% on-site position.
• Less than 20% travel required.

Job Type:

• Full-time

Pay:

• $60,000.00 - $100,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location:

• In person