Grow your career at Cedars-Sinai!

We reflect Cedars-Sinai's steadfast dedication to heart disease and research innovation giving patients access to the highest level of care. Year after year, thousands of people trust their hearts to Smidt Heart Institute at Cedars-Sinai. Our cardiologists, cardiac surgeons and niche care teams treat the full spectrum of heart disease and disorders, while our investigators continue to advance the field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to a growing array of minimally invasive procedures, Cedars-Sinai continues to stand at the forefront of technology, innovation and discovery improving patient outcomes.

Join our team and use your skills with an organization known nationally for excellence in research!

This role will work closely with other members of the research, design, and development team and will be responsible for department innovation's design and development of new implant and catheter products through development and oversight of technical processes, product changes and device improvements. Individual will collaborate closely with key collaborators (i.e. marketing, quality, operations, finance and clinical team) to support organizational growth and strategic goals related to innovative product design and development.

Develop, design, and improve prototyping for implant and catheters in the neurovascular, structural heart, peripheral vascular, and endovascular specialties, ensuring alignment with clinical needs, market trends, quality standards, and regulatory requirements.

• Collaborate with contract manufacturers to further develop products resulting from Cedars-Sinai internally developed prototypes and concepts.
• Collaborates with the Principal Investigator and lead engineer to carry out medical device needs in structural heart, endovascular and peripheral vascular space to develop value-based patent ideas and intellectual property.
• Applies software like abaqus, solidworks, creo, 3mensio, and mimics for computer aided design modeling of ideas.
• Plan and prepare quality system documentation specifications and detailed engineering drawings while developing new concepts to help support FDA submission and ensuring compliance for conducting first-in-human studies.
• Prepare and present sophisticated engineering design documentation, reports, and presentations to various collaborators and multi-functional teams, which may include clinical and research personnel, investors and regulatory bodies.
• Prove concept and technology feasibility and progress concepts and/or technologies into new product development through bench studies and animal studies.
• Prepare and submit regulatory reports for compliance (i.e. FDA 510(k) and PMA submissions) to the regulatory bodies including FDA to facilitate early human use of products post development.
• Drive continuous improvement initiatives and finds opportunities to improve product designs and streamline development processes. Participate in root cause investigations and corrective and preventative actions and implement risk management processes and tools to mitigate risks.
• Design and implement testing protocols to evaluate the performance, safety, and durability of products.

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or related field required.
• 10 years Experience in medical device industry with concepts and product development required.
• 5 years project management experience overseeing aspects of product life cycle.